Harbor is seeking a Senior Consultant- ELM (Enterprise Legal Management) to join our dynamic Legal Technology & Operations – Corporate Legal Technology team. Our team is at the forefront of innovation and delivery for our corporate legal department clients, with deep experience in evaluating legal processes and technology, developing technology roadmaps, system selection and implementation, and change management. We work with leading vendors allowing clients to benefit from our product-specific expertise and market perspective. We serve both as advisors and as experienced, scalable hands-on resources, collaborating with our clients to contain risk and cost through operational improvement, efficient data management, and technology usage.

As a part of the Corporate Legal Technology Team, we will rely on you to work closely with Harbor project team members and clients to lead requirements gathering and analysis, executing against legal technology best practices, and leveraging our methodologies to facilitate the selection, implementation and/or optimization of legal technology systems and tools leveraged by our corporate law department clients. As a Senior Consultant, you will be expected to work with senior and junior-level internal resources, to help manage the project lifecycle.  This is a full-time, remote position that can be worked from anywhere in the US or Canada.

Job Duties and Responsibilities:

• Leverage industry knowledge, organizational skills, and project management experience to support all aspects of projects including facilitating requirements gathering, preparing documentation of processes, and helping to implement identified solutions
• Support client business process review, identify key client business requirements and support transformation of business requirements to technical requirements and design
• Draft deliverables during a project lifecycle including findings and recommendations, functional and technical design documents, data maps, test scripts, training and communication plans, training guides.
• Configure and develop technologies based on technical requirements and design
• Administer system testing, track defects, and collaborate with technology providers and clients to resolve defects (on technology related projects)
• Assist with management of project scope, schedules, workplans, timelines, and budgets
• Manage client expectations and project scope, communicating directly with clients to continually foster relationships
• Become proficient in specific legal technologies related to active projects
• Research and stay abreast of legal industry and technology trends, product developments, best practices, emerging technologies and the use of AI
• Assist in business development efforts such as proposals, workplans, and presentations
• Seek opportunities to proactively contribute to the growth and development of the Corporate Legal Technology team and Harbor

Experience, Education and Other Qualifications:

• 3+ years of relevant experience in the legal or consulting industry (i.e., in-house legal department, law firm, legal software provider, consulting firm)
• 3+ years experience in legal technology contributing to assessments, requirements gathering, system design, configuration, implementation, testing and deployment, with experience implementing ELM/eBilling + Matter Management, Legal Hold, and Legal Workflow tools.
• Experience with TeamConnect, CounselLink is preferred, also WK T360, Onit/SimpleLegal, Litify, Legal Tracker, Brightflag, doeLegal, and similar systems; this experience should include related data migration and integration workstreams
• Four- year degree in Finance, Business, Computer Science, Software Engineering, Information Science, Economics, Statistics, Accounting, Data & Analytics, and the like, or equivalent combination of experience and education
• Understanding of the implementation process including requirement analysis, design, configuration/development, migration, testing, and change management
• Strong observational, analytical, numerical reasoning, business acumen, problem solving and leadership skills; proficient in process mapping
• Effective communication and storytelling skills (written and spoken) and a client service-centric mindset
• Strong organizational skills with the ability to work on multiple projects simultaneously, prioritize tasks, maintaining exacting standards for work product and attention to detail
• Project management experience, including managing tasks, resources, and financials on various stages of technology implementation projects
• Excels in a cooperative team environment; takes initiative to forward team operational efficiency through improved methodologies; able to ideate and create client deliverables with moderate oversight
• Positive, enthusiastic attitude and entrepreneurial spirit with an eagerness to quickly learn and develop new subject matter expertise and business skills
• Advanced computer skills (primarily Excel, Word, PowerPoint, and Visio); familiarity with use of Outlook, Teams and SharePoint as collaboration tools

About Us:

Harbor is the preeminent provider of expert services across strategy, legal technology, operations, and intelligence. Our globally integrated team of 900+ strategists, technologists, and specialists navigate alongside our clients – leading law firms, corporations, and their law departments – to provide essential resources and invaluable insights. Anchored in a rich heritage of deep knowledge, steadfast relationships, and mutual respect, our unwavering dedication lies in shaping the future of the legal industry and fostering enduring partnerships within our community and ecosystem.

Harbor is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, sexual orientation, gender identity, marital status, civil union status, national origin, ancestry, age, parental status, disabled status, veteran status, or any other legally protected classification, in accordance with applicable law.

Harbor is seeking a Senior Consultant- ELM (Enterprise Legal Management) to join our dynamic Legal Technology & Operations – Corporate Legal Technology team. Our team is at the forefront of innovation and delivery for our corporate legal department clients, with deep experience in evaluating legal processes and technology, developing technology roadmaps, system selection and implementation, and change management. We work with leading vendors allowing clients to benefit from our product-specific expertise and market perspective. We serve both as advisors and as experienced, scalable hands-on resources, collaborating with our clients to contain risk and cost through operational improvement, efficient data management, and technology usage.

As a part of the Corporate Legal Technology Team, we will rely on you to work closely with Harbor project team members and clients to lead requirements gathering and analysis, executing against legal technology best practices, and leveraging our methodologies to facilitate the selection, implementation and/or optimization of legal technology systems and tools leveraged by our corporate law department clients. As a Senior Consultant, you will be expected to work with senior and junior-level internal resources, to help manage the project lifecycle.  This is a full-time, remote position that can be worked from anywhere in the US or Canada.

Job Duties and Responsibilities:

• Leverage industry knowledge, organizational skills, and project management experience to support all aspects of projects including facilitating requirements gathering, preparing documentation of processes, and helping to implement identified solutions
• Support client business process review, identify key client business requirements and support transformation of business requirements to technical requirements and design
• Draft deliverables during a project lifecycle including findings and recommendations, functional and technical design documents, data maps, test scripts, training and communication plans, training guides.
• Configure and develop technologies based on technical requirements and design
• Administer system testing, track defects, and collaborate with technology providers and clients to resolve defects (on technology related projects)
• Assist with management of project scope, schedules, workplans, timelines, and budgets
• Manage client expectations and project scope, communicating directly with clients to continually foster relationships
• Become proficient in specific legal technologies related to active projects
• Research and stay abreast of legal industry and technology trends, product developments, best practices, emerging technologies and the use of AI
• Assist in business development efforts such as proposals, workplans, and presentations
• Seek opportunities to proactively contribute to the growth and development of the Corporate Legal Technology team and Harbor

Experience, Education and Other Qualifications:

• 3+ years of relevant experience in the legal or consulting industry (i.e., in-house legal department, law firm, legal software provider, consulting firm)
• 3+ years experience in legal technology contributing to assessments, requirements gathering, system design, configuration, implementation, testing and deployment, with experience implementing ELM/eBilling + Matter Management, Legal Hold, and Legal Workflow tools.
• Experience with TeamConnect, CounselLink is preferred, also WK T360, Onit/SimpleLegal, Litify, Legal Tracker, Brightflag, doeLegal, and similar systems; this experience should include related data migration and integration workstreams
• Four- year degree in Finance, Business, Computer Science, Software Engineering, Information Science, Economics, Statistics, Accounting, Data & Analytics, and the like, or equivalent combination of experience and education
• Understanding of the implementation process including requirement analysis, design, configuration/development, migration, testing, and change management
• Strong observational, analytical, numerical reasoning, business acumen, problem solving and leadership skills; proficient in process mapping
• Effective communication and storytelling skills (written and spoken) and a client service-centric mindset
• Strong organizational skills with the ability to work on multiple projects simultaneously, prioritize tasks, maintaining exacting standards for work product and attention to detail
• Project management experience, including managing tasks, resources, and financials on various stages of technology implementation projects
• Excels in a cooperative team environment; takes initiative to forward team operational efficiency through improved methodologies; able to ideate and create client deliverables with moderate oversight
• Positive, enthusiastic attitude and entrepreneurial spirit with an eagerness to quickly learn and develop new subject matter expertise and business skills
• Advanced computer skills (primarily Excel, Word, PowerPoint, and Visio); familiarity with use of Outlook, Teams and SharePoint as collaboration tools

About Us:

Harbor is the preeminent provider of expert services across strategy, legal technology, operations, and intelligence. Our globally integrated team of 900+ strategists, technologists, and specialists navigate alongside our clients – leading law firms, corporations, and their law departments – to provide essential resources and invaluable insights. Anchored in a rich heritage of deep knowledge, steadfast relationships, and mutual respect, our unwavering dedication lies in shaping the future of the legal industry and fostering enduring partnerships within our community and ecosystem.

Harbor is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, sexual orientation, gender identity, marital status, civil union status, national origin, ancestry, age, parental status, disabled status, veteran status, or any other legally protected classification, in accordance with applicable law.

Immunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. As trailblazer in anti-FcRn technology, the Company is developing innovative, targeted therapies to meet the complex and variable needs of people with autoimmune diseases.

Organizational Overview:

Immunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. As trailblazer in anti-FcRn technology, the Company is developing innovative, targeted therapies to meet the complex and variable needs of people with autoimmune diseases.

The Role:

This highly dynamic team is seeking a motivated and entrepreneurial Associate Director, Regulatory Affairs Strategy, to play a key role on our cross-functional R&D team. In this role, you will be responsible for supporting and contribute to innovative global regulatory strategies that expedite development, maximize the probability of success, identify regulatory opportunities, and mitigate risks. The individual in this position will have the unique opportunity to grow and mentor regulatory scientists on regulatory requirements and regulatory environmental trends, as well as help shape the regulatory approach in a rapid-growth biotech startup.

Key Responsibilities:

• Support and contribute to regulatory strategies that expedite development and maximize the probability of success based on knowledge of regulatory environment.
• Help mitigate identified regulatory risks.
• Understand global regulatory requirements to support strategy.
• Collaborate to ensure regulatory strategy is understood by project teams.
• Play a hands-on role in planning, preparing, and coordinating regulatory documents for submission to global health authorities in support of regulatory filings, such as INDs, BLAs, MAAs, CTAs/IMPDs, amendments, annual updates, briefing documents, and responses to Agency queries.
• Close collaboration with internal and external cross-functional team members to ensure the achievement of submissions and timely approvals of applications.
• Support interactions with FDA and other Health Authorities.
• Help formulate communications of project updates and risks to senior management and stakeholders across the organization.
• Track regulatory commitments, deliverables, and overall project timelines.
• Maintain up-to-date knowledge and understanding of global regulatory requirements.
• Contribute to the development of policies and procedures in alignment with GxPs, global regulatory requirements and guidance, and corporate objectives.
• Provide hands-on support to cross-functional teams in planning, preparing, and coordinating documents for submission to global authorities in support of regulatory filings, such as INDs, BLAs, MAAs, CTAs/IMPDs, amendments, annual updates, briefing documents, and responses to Agency queries.

Requirements:

• 8+ years of biopharmaceutical experience, which includes at least 4 years of direct experience in Regulatory Affairs.
• An advanced degree (Master’s) in a relevant scientific discipline is preferred.
• Experience in biologics or small molecule drug development, parenteral products, including combination products, and orphan/rare disease product development.
• Experience in supporting and implementing regulatory strategies in a global environment.
• Comprehensive understanding of applicable global regulations, guidance, and practices.
• Demonstrated hands-on experience in the preparation and submission of global regulatory documents, including clinical trial applications and maintenance (IND/CTA), NDA/BLA/MAA, briefing documents, Clinical Trial Applications, and Agency queries.
• Prior experience in supporting interactions with FDA and other global regulatory authorities.
• Excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
• Ability to problem-solve regulatory issues and apply learnings.
• Works collaboratively and efficiently with multiple functional areas in a fast-paced matrixed team environment, including functional team members, company management, and external vendors and contract organizations.
• Strong team and project management skills
• Strong verbal and written communication skills.
• Results-oriented individual with a strong work ethic and ability to complete projects with oversight.
• Knowledge of GxP, ICH, FDA, EMA, and other global regulations and guidance.
• Attention to detail and an ability to balance analytical and critical-thinking skills to support data-driven, strategically oriented regulatory proposals and documents.
• Experience supporting regulatory strategies for biologics and/or rare disease development programs.
• Commitment to company values and culture.
• Proven ability to adapt to change and uncertainty as projects evolve.
• Self-motivated, with initiative and the ability to take ownership of and follow through with specific tasks.
• Ability to multi-task and adjust priorities quickly while working under tight deadlines.
• Strong PC experience and demonstrated proficiency in MS Office (Outlook, Word, Excel, PowerPoint, Project).

Work Environment:

• Remote-based
• Dynamic, interactive, fast-paced, and entrepreneurial environment
• Domestic or international travel is required (10-20%)

Salary range for posting

$185,000—$190,000 USD

Compensation is based on a number of factors, including market location, and may vary depending on job-related knowledge, skills, and experience. Equity and other forms of compensation may be provided as part of a total compensation package, in addition to a full range of medical, dental, vision, 401k, and other benefits, including unlimited paid time off and parental leave.

About the jobMercor connects elite creative and technical talent with leading AI research labs.

About the jobMercor connects elite creative and technical talent with leading AI research labs.

Company Description

About AbbVie

AbbVie’s mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

The Senior Manager, Regulatory Affairs US & Canada Strategy Lead – Aesthetics Device is responsible for the development and implementation of US and Canada regulatory strategic and tactical planning (RSTP) for assigned on market products or those products in development. This individual demonstrates the ability to combine knowledge of scientific, regulatory & business issues to enable development and commercialization of products that are developed, manufactured or distributed to meet relevant US and Canada regulatory requirements. They assure that regulatory strategies defined within the Global Regulatory Product Team (GRPT), are effectively implemented and maintained in line with changing regulatory and business needs. This individual identifies and gathers data needed to support filings, responses to inquiries, and registration maintenance to enable commercialization of products that are developed, manufactured, or distributed to meet relevant US and Canada regulatory requirements.

Responsibilities:

• This individual has responsibility for products/multiple driver indications for a product within a Therapeutic Area and supports the Global Regulatory Lead (GRL), in the development & execution of the regulatory strategy.  Area of responsibility has significant regulatory impact and possibly significant impact to AbbVie overall.
• Leads total product lifecycle activities, including product/manufacturing change assessments, post-approval requirements, addressing Health Authority information requests, annual reporting, and internal regulatory requests among others, providing business-critical decision and strategy support.
• Manages interface with Health Authority (FDA) for key projects/issues, including direct collaboration with review division personnel.  May also serve as primary liaison and interface with FDA for meetings, teleconferences and coordinates preparation of FDA meeting briefing packages and responses.
• Advise internal customers who may contribute to regulated communication on Regulatory/FDA issues including Public Affairs, Clinical Development, Legal, and others such as Commercial.
• Operates independently, with recognition of when to consult management.  Makes decisions and plans for operations (workflow, assignments) within area of responsibility with minimal direction.
• Coordinates, prepares and/or supervises the preparation and review of regulatory submissions consistent within US and Canada regulatory requirements and guidelines and assures complete and timely response to Health Authorities during application review.  Ensures application of established policies and best practice regulatory standards for all US/Canada product registrations.
• Demonstrates understanding of current US and Canada regulations and guidance, political and legal climate and industry practices to assist in meeting organizational goals.  Broadly applies regulatory/technical knowledge of government regulations and skills across therapeutic areas.
• Presents pertinent regulatory information to appropriate cross-functional teams.
• Operates in compliance with regulations, company policies, procedures, and guidance in alignment with regulatory product strategy and the Quality Dossier Program (QDP).

Qualifications

Minimum Qualifications:

• Advanced degree (e.g. PharmD, PhD, MS) or Regulatory certification
• 5+ years Regulatory, R&D, or equivalent industry-related experience.
• Experience in medical device space
• Experience with digital health/software
• Proven skill at implementing successful affiliate regulatory strategies (US or Canada experience preferred).
• Experience working in a complex and matrix environment.
• Experience interfacing with government regulatory agencies.

Preferred Qualifications:

• Preferred: Advanced Degree and/or Certifications or direct experience with pharmaceutical regulatory activities
• Global regulatory experience is a plus.

Other Required Skills:

• Demonstrates excellent negotiation skills, problem solving skills and builds consensus.
• Demonstrates effective communication skills in written and oral channels both within Regulatory and across the organization.
• Able to deliver challenging messages effectively without compromising important business relationships.

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. ​
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.​
• This job is eligible to participate in our long-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company’s sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.​

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html

Company Description

About AbbVie

AbbVie’s mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

The Senior Manager, Regulatory Affairs US & Canada Strategy Lead – Aesthetics Device is responsible for the development and implementation of US and Canada regulatory strategic and tactical planning (RSTP) for assigned on market products or those products in development. This individual demonstrates the ability to combine knowledge of scientific, regulatory & business issues to enable development and commercialization of products that are developed, manufactured or distributed to meet relevant US and Canada regulatory requirements. They assure that regulatory strategies defined within the Global Regulatory Product Team (GRPT), are effectively implemented and maintained in line with changing regulatory and business needs. This individual identifies and gathers data needed to support filings, responses to inquiries, and registration maintenance to enable commercialization of products that are developed, manufactured, or distributed to meet relevant US and Canada regulatory requirements.

Responsibilities:

• This individual has responsibility for products/multiple driver indications for a product within a Therapeutic Area and supports the Global Regulatory Lead (GRL), in the development & execution of the regulatory strategy.  Area of responsibility has significant regulatory impact and possibly significant impact to AbbVie overall.
• Leads total product lifecycle activities, including product/manufacturing change assessments, post-approval requirements, addressing Health Authority information requests, annual reporting, and internal regulatory requests among others, providing business-critical decision and strategy support.
• Manages interface with Health Authority (FDA) for key projects/issues, including direct collaboration with review division personnel.  May also serve as primary liaison and interface with FDA for meetings, teleconferences and coordinates preparation of FDA meeting briefing packages and responses.
• Advise internal customers who may contribute to regulated communication on Regulatory/FDA issues including Public Affairs, Clinical Development, Legal, and others such as Commercial.
• Operates independently, with recognition of when to consult management.  Makes decisions and plans for operations (workflow, assignments) within area of responsibility with minimal direction.
• Coordinates, prepares and/or supervises the preparation and review of regulatory submissions consistent within US and Canada regulatory requirements and guidelines and assures complete and timely response to Health Authorities during application review.  Ensures application of established policies and best practice regulatory standards for all US/Canada product registrations.
• Demonstrates understanding of current US and Canada regulations and guidance, political and legal climate and industry practices to assist in meeting organizational goals.  Broadly applies regulatory/technical knowledge of government regulations and skills across therapeutic areas.
• Presents pertinent regulatory information to appropriate cross-functional teams.
• Operates in compliance with regulations, company policies, procedures, and guidance in alignment with regulatory product strategy and the Quality Dossier Program (QDP).

Qualifications

Minimum Qualifications:

• Advanced degree (e.g. PharmD, PhD, MS) or Regulatory certification
• 5+ years Regulatory, R&D, or equivalent industry-related experience.
• Experience in medical device space
• Experience with digital health/software
• Proven skill at implementing successful affiliate regulatory strategies (US or Canada experience preferred).
• Experience working in a complex and matrix environment.
• Experience interfacing with government regulatory agencies.

Preferred Qualifications:

• Preferred: Advanced Degree and/or Certifications or direct experience with pharmaceutical regulatory activities
• Global regulatory experience is a plus.

Other Required Skills:

• Demonstrates excellent negotiation skills, problem solving skills and builds consensus.
• Demonstrates effective communication skills in written and oral channels both within Regulatory and across the organization.
• Able to deliver challenging messages effectively without compromising important business relationships.

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. ​
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.​
• This job is eligible to participate in our long-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company’s sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.​

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html

Company Description

About AbbVie

AbbVie’s mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

The Senior Manager, Regulatory Affairs US & Canada Strategy Lead – Aesthetics Device is responsible for the development and implementation of US and Canada regulatory strategic and tactical planning (RSTP) for assigned on market products or those products in development. This individual demonstrates the ability to combine knowledge of scientific, regulatory & business issues to enable development and commercialization of products that are developed, manufactured or distributed to meet relevant US and Canada regulatory requirements. They assure that regulatory strategies defined within the Global Regulatory Product Team (GRPT), are effectively implemented and maintained in line with changing regulatory and business needs. This individual identifies and gathers data needed to support filings, responses to inquiries, and registration maintenance to enable commercialization of products that are developed, manufactured, or distributed to meet relevant US and Canada regulatory requirements.

Responsibilities:

• This individual has responsibility for products/multiple driver indications for a product within a Therapeutic Area and supports the Global Regulatory Lead (GRL), in the development & execution of the regulatory strategy.  Area of responsibility has significant regulatory impact and possibly significant impact to AbbVie overall.
• Leads total product lifecycle activities, including product/manufacturing change assessments, post-approval requirements, addressing Health Authority information requests, annual reporting, and internal regulatory requests among others, providing business-critical decision and strategy support.
• Manages interface with Health Authority (FDA) for key projects/issues, including direct collaboration with review division personnel.  May also serve as primary liaison and interface with FDA for meetings, teleconferences and coordinates preparation of FDA meeting briefing packages and responses.
• Advise internal customers who may contribute to regulated communication on Regulatory/FDA issues including Public Affairs, Clinical Development, Legal, and others such as Commercial.
• Operates independently, with recognition of when to consult management.  Makes decisions and plans for operations (workflow, assignments) within area of responsibility with minimal direction.
• Coordinates, prepares and/or supervises the preparation and review of regulatory submissions consistent within US and Canada regulatory requirements and guidelines and assures complete and timely response to Health Authorities during application review.  Ensures application of established policies and best practice regulatory standards for all US/Canada product registrations.
• Demonstrates understanding of current US and Canada regulations and guidance, political and legal climate and industry practices to assist in meeting organizational goals.  Broadly applies regulatory/technical knowledge of government regulations and skills across therapeutic areas.
• Presents pertinent regulatory information to appropriate cross-functional teams.
• Operates in compliance with regulations, company policies, procedures, and guidance in alignment with regulatory product strategy and the Quality Dossier Program (QDP).

Qualifications

Minimum Qualifications:

• Advanced degree (e.g. PharmD, PhD, MS) or Regulatory certification
• 5+ years Regulatory, R&D, or equivalent industry-related experience.
• Experience in medical device space
• Experience with digital health/software
• Proven skill at implementing successful affiliate regulatory strategies (US or Canada experience preferred).
• Experience working in a complex and matrix environment.
• Experience interfacing with government regulatory agencies.

Preferred Qualifications:

• Preferred: Advanced Degree and/or Certifications or direct experience with pharmaceutical regulatory activities
• Global regulatory experience is a plus.

Other Required Skills:

• Demonstrates excellent negotiation skills, problem solving skills and builds consensus.
• Demonstrates effective communication skills in written and oral channels both within Regulatory and across the organization.
• Able to deliver challenging messages effectively without compromising important business relationships.

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. ​
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.​
• This job is eligible to participate in our long-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company’s sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.​

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html

Company Description

About AbbVie

AbbVie’s mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

The Senior Associate, RA CMC is responsible for ensuring RA-CMC post approval change objectives are met by project managing marketed product variations including authoring and compilation of chemistry, manufacturing, and control (CMC) sections to ensure timely preparation of submission documents.  The Senior Associate will also ensure proper communication with all key partners in the functional departments in support of regulatory filings.

Responsibilities:

• Manage, compile, and author CMC sections of marketed product variations with minimal management oversight.  Update simple CMC documents independently.
• Partner with RA CMC Project Leads to create and develop content plans, bundling strategies, and project timelines.
• Collaborate with diverse functional groups to ensure file-ability and acceptance of CMC sections.
• Manage assigned projects to ensure thoroughness, accuracy, and timeliness of CMC dossiers and responses. Independently run team review and management reviews of submission documents.
• Ensure CMC expectations including CTD content, structural and formatting requirements are being met for assigned projects.
• Provide input into and utilize current best practices for use of regulatory business systems within the group.
• Timely communication of systems issues to management.
• Communicate content gaps and risks for variation documents identified by RA CMC Project Leads.
• Provide guidance on use of submission document templates.
• Support annual reports and renewals (ad hoc baseline support)
• This role works a hybrid work schedule (3 days in office & 2 days remotely) from the Lake County, IL; Waltham, MA or Irvine, CA AbbVie headquarters.

Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required

Qualifications

• Minimum of a BA/BS Degree in Chemical, and/or, Biological Sciences/relevant discipline
• Required Experience: 4 years pharmaceutical or industry related experience. 1-2 years in quality systems or cross functional project management
• Preferred Experience: 5 years pharmaceutical experience including 1-2 years in regulatory affairs or 1-2 years in Discovery, R&D, or Manufacturing
• Strong working knowledge of manufacturing unit operations or CTD structure
• Superior oral and written communication skills
• Ability to work cooperatively with all levels and types of global personnel required
• Experience working with electronic document management systems
• Ability to work independently under pressure and manage multiple projects simultaneously
• Detail/accuracy oriented
• Collaborative and willing to learn
• Familiarity with US and other international regulatory requirements for drug product dossiers

Additional Information

​Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. ​
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.​
• This job is eligible to participate in our short-term incentive programs. ​

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of  any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company’s sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law. ​

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html

Company Description

About AbbVie

AbbVie’s mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

The Senior Manager Regulatory Affairs, Global Reg Strategy US & Canada (Hybrid) is responsible for the development and implementation of US and Canada regulatory strategic and tactical planning (RSTP) for assigned on market products or those products in development.

They assure that regulatory strategies defined within the GRPT, are effectively implemented and maintained in line with changing regulatory and business needs. This individual identifies and gathers data needed to support filings, responses to inquiries, and registration maintenance to enable commercialization of products that are developed, manufactured or distributed to meet relevant US and Canada regulatory requirements.

Responsibilities:

• Responsible for a product(s) or products with multiple driver indications within a Therapeutic Area and supports the Manager (Global Regulatory Lead (GRL), Associate Director, or Director), in the development & execution of the regulatory strategy.
• Assigned matters may have a moderate impact on business activities and operations.
• Serves as HA liaison and interfaces with FDA for meetings, teleconferences and coordinates preparation and completion of FDA meeting briefing packages and responses.
• Advise internal customers who may contribute to regulated communication on Regulatory/FDA issues including Public Affairs, Clinical Development, Legal, and others such as Commercial.
• Functions independently in negotiation and decision-making for project related issues that have cross-functional impact.
• Assists in the development, training of staff members.
• Key contributor responsible for the preparation and review of regulatory submissions consistent within US and Canada regulatory requirements and guidelines and assures complete and timely response to Health Authorities during application review.
• Supports the regulatory submission and approval process.
• Broadly applies regulatory/technical knowledge of government regulations and skills across therapeutic areas.
• Recommends and implements changes to difficult projects based on knowledge and expertise, accurate interpretation of US and Canada government regulations, guidances, as well as corporate policies and management-related considerations.
• Presents pertinent regulatory information to appropriate cross-functional areas.
• Operates in compliance with regulations, company policies, procedures, and guidance in alignment with regulatory product strategy and the Quality Dossier Program (QDP).

Qualifications

Minimum Qualifications:

• Bachelor’s degree (pharmacy, biology, chemistry, pharmacology or related)
• 6 years Regulatory, R&D, or Industry-related experience.
• Experience working in a complex and matrix environment.
• Experience interfacing with government regulatory agencies.

Preferred Qualifications:

• 2-3 years in pharmaceutical regulatory activities
• Global regulatory experience is a plus.
• Advanced Degree a plus
• Certifications a plus

Other Required Skills:

• Excellent negotiation skills, problem solving skills and builds consensus.
• Effective communication skills in written and oral channels both within Regulatory and across the organization.
• Able to deliver challenging messages effectively without compromising important business relationships.
• Proven skill at implementing successful US and Canada regulatory strategies regulatory strategies.

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of thisposting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location,and we may ultimately pay more or less than the posted range. This range may be modified in the future. ​

• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.​

• This job is eligible to participate in our long-term incentive programs. ​

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission,incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company’s sole and absolute discretion unless anduntil paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.​

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html

Company Description

About AbbVie

AbbVie’s mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

The Senior Manager Regulatory Affairs, Global Reg Strategy US & Canada (Hybrid) is responsible for the development and implementation of US and Canada regulatory strategic and tactical planning (RSTP) for assigned on market products or those products in development.

They assure that regulatory strategies defined within the GRPT, are effectively implemented and maintained in line with changing regulatory and business needs. This individual identifies and gathers data needed to support filings, responses to inquiries, and registration maintenance to enable commercialization of products that are developed, manufactured or distributed to meet relevant US and Canada regulatory requirements.

Responsibilities:

• Responsible for a product(s) or products with multiple driver indications within a Therapeutic Area and supports the Manager (Global Regulatory Lead (GRL), Associate Director, or Director), in the development & execution of the regulatory strategy.
• Assigned matters may have a moderate impact on business activities and operations.
• Serves as HA liaison and interfaces with FDA for meetings, teleconferences and coordinates preparation and completion of FDA meeting briefing packages and responses.
• Advise internal customers who may contribute to regulated communication on Regulatory/FDA issues including Public Affairs, Clinical Development, Legal, and others such as Commercial.
• Functions independently in negotiation and decision-making for project related issues that have cross-functional impact.
• Assists in the development, training of staff members.
• Key contributor responsible for the preparation and review of regulatory submissions consistent within US and Canada regulatory requirements and guidelines and assures complete and timely response to Health Authorities during application review.
• Supports the regulatory submission and approval process.
• Broadly applies regulatory/technical knowledge of government regulations and skills across therapeutic areas.
• Recommends and implements changes to difficult projects based on knowledge and expertise, accurate interpretation of US and Canada government regulations, guidances, as well as corporate policies and management-related considerations.
• Presents pertinent regulatory information to appropriate cross-functional areas.
• Operates in compliance with regulations, company policies, procedures, and guidance in alignment with regulatory product strategy and the Quality Dossier Program (QDP).

Qualifications

Minimum Qualifications:

• Bachelor’s degree (pharmacy, biology, chemistry, pharmacology or related)
• 6 years Regulatory, R&D, or Industry-related experience.
• Experience working in a complex and matrix environment.
• Experience interfacing with government regulatory agencies.

Preferred Qualifications:

• 2-3 years in pharmaceutical regulatory activities
• Global regulatory experience is a plus.
• Advanced Degree a plus
• Certifications a plus

Other Required Skills:

• Excellent negotiation skills, problem solving skills and builds consensus.
• Effective communication skills in written and oral channels both within Regulatory and across the organization.
• Able to deliver challenging messages effectively without compromising important business relationships.
• Proven skill at implementing successful US and Canada regulatory strategies regulatory strategies.

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of thisposting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location,and we may ultimately pay more or less than the posted range. This range may be modified in the future. ​

• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.​

• This job is eligible to participate in our long-term incentive programs. ​

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission,incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company’s sole and absolute discretion unless anduntil paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.​

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html

Company Description

About AbbVie

AbbVie’s mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

The Senior Manager Regulatory Affairs, Global Reg Strategy US & Canada (Hybrid) is responsible for the development and implementation of US and Canada regulatory strategic and tactical planning (RSTP) for assigned on market products or those products in development.

They assure that regulatory strategies defined within the GRPT, are effectively implemented and maintained in line with changing regulatory and business needs. This individual identifies and gathers data needed to support filings, responses to inquiries, and registration maintenance to enable commercialization of products that are developed, manufactured or distributed to meet relevant US and Canada regulatory requirements.

Responsibilities:

• Responsible for a product(s) or products with multiple driver indications within a Therapeutic Area and supports the Manager (Global Regulatory Lead (GRL), Associate Director, or Director), in the development & execution of the regulatory strategy.
• Assigned matters may have a moderate impact on business activities and operations.
• Serves as HA liaison and interfaces with FDA for meetings, teleconferences and coordinates preparation and completion of FDA meeting briefing packages and responses.
• Advise internal customers who may contribute to regulated communication on Regulatory/FDA issues including Public Affairs, Clinical Development, Legal, and others such as Commercial.
• Functions independently in negotiation and decision-making for project related issues that have cross-functional impact.
• Assists in the development, training of staff members.
• Key contributor responsible for the preparation and review of regulatory submissions consistent within US and Canada regulatory requirements and guidelines and assures complete and timely response to Health Authorities during application review.
• Supports the regulatory submission and approval process.
• Broadly applies regulatory/technical knowledge of government regulations and skills across therapeutic areas.
• Recommends and implements changes to difficult projects based on knowledge and expertise, accurate interpretation of US and Canada government regulations, guidances, as well as corporate policies and management-related considerations.
• Presents pertinent regulatory information to appropriate cross-functional areas.
• Operates in compliance with regulations, company policies, procedures, and guidance in alignment with regulatory product strategy and the Quality Dossier Program (QDP).

Qualifications

Minimum Qualifications:

• Bachelor’s degree (pharmacy, biology, chemistry, pharmacology or related)
• 6 years Regulatory, R&D, or Industry-related experience.
• Experience working in a complex and matrix environment.
• Experience interfacing with government regulatory agencies.

Preferred Qualifications:

• 2-3 years in pharmaceutical regulatory activities
• Global regulatory experience is a plus.
• Advanced Degree a plus
• Certifications a plus

Other Required Skills:

• Excellent negotiation skills, problem solving skills and builds consensus.
• Effective communication skills in written and oral channels both within Regulatory and across the organization.
• Able to deliver challenging messages effectively without compromising important business relationships.
• Proven skill at implementing successful US and Canada regulatory strategies regulatory strategies.

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of thisposting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location,and we may ultimately pay more or less than the posted range. This range may be modified in the future. ​

• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.​

• This job is eligible to participate in our long-term incentive programs. ​

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission,incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company’s sole and absolute discretion unless anduntil paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.​

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html

About the jobMercor connects elite creative and technical talent with leading AI research labs.

Role Title: Corporate Counsel Job Type: Contractor Location: Remote Job Summary:We are seeking seasoned in-house Corporate Counsels for a part-time role at the forefront of legal AI.

We’re currently hiring a Senior Regulatory Permitting Specialist in the Sacramento/Central Valley region. On Team 12, you will work closely with WRA’s Principals, Directors, and Executive-level leadership to develop, manage, and deliver multifaceted regulatory projects primarily in California’s Central Valley and Foothills region. WRA is committed to growing in the Sacramento and San Joaquin Valleys and Foothills as a focus of our 2030 strategic plan, and this hire will support existing senior-level staff in that goal.

In this role you will work collaboratively between clients, regulators, and an interdisciplinary WRA team to develop innovative approaches, lead interesting consultation processes, and support project implementation. This is a remote position within the state of California,: however, the person hired for this role will be expected to be at various on-site locations including field sites, client or agency offices in the greater Sacramento and Central Valley area. Occasional visits to WRA’s office locations are also expected as needed to meet project needs. This role reports to Rob Schell, Wildlife and Fisheries Director.

In this role, you will:

• Work with Principals as well as Director and Executive-level staff, including subject matter experts, engineers, attorneys, clients, prime or subconsultants to develop a project from idea, through planning and permit consultations in support of critical infrastructure and development in California’s Central Valley and Foothills

• Merge technical expertise with regulatory experience to guide and advise clients on project due diligence, design, opportunities and constraints to develop and deliver a permitting strategy, schedule, and budget that reflects client priorities

• Coordinate, delegate, and oversee multidisciplinary teams, stakeholders, staff, and subconsultants on the preparation of technical studies necessary to support the permitting process

• Oversee or directly prepare permit applications

• Proactively manage budgets, prepare scopes of work and change orders.

• Identify and communicate project risks to Principal-level staff

• Oversee and mentor early career professionals on regulatory processes, project management, and professional development

• Participate in internal and external thought leadership at conferences or professional technical groups through publications, presentations, white papers, panel discussions, or similar

To be successful in this role, you will need:

• A bachelor’s degree in biological sciences, engineering, policy, or related field

• At least 10 years of professional experience working in the consulting field

• At least 6 years of expertise preparing and consulting on 401, 404, 1600 LSAA, USFWS/NMFS Section 7 or Section 10 consultations, CDFW 2081 ITPs

• Proven experience building and managing across multidisciplinary teams

• Proven track record in a supervisory or leadership role

• Demonstrated experience in Transportation, Water, or Mine/Quarry Markets

• At least 5 years of project management experience, including preparing scopes of work, budgets and change orders

• At least 5 years working in California’s Central Valley or Foothills regions

• A growth mindset

• Strong written and verbal communication skills, with the ability to present technical information to a lay audience

• A valid driver’s license, reliable transportation (while WRA has fleet vehicles that can be reserved for field use, during busy field seasons a truck may not always be available) and willingness to travel to field sites and meetings

• The ability to walk, hike, and work outside for long periods of time

Desired but not required skills:

• Specialized expertisewith Mitigation, SMARA, FERC

• Business Development experience

• Experience working on competitive proposals

• Strong leadership skills

WRA has an established internal leveling system for our staff that maps to salary bands that have been informed by market data. Our leveling system is dependent on years of relevant industry experience, education, and the level of responsibility and autonomy at which you’re expected to operate.

The salary range for this position is $108,000 - $146,000 which represents 2 job levels that WRA is open to considering for this role. In your first conversation with our recruiter, you may discuss leveling and compensation to make sure that expectations are aligned. Additionally, while the position is being advertised as a Senior Regulatory Permitting Specialist, based on leveling conversations, we may determine that Regulatory Permitting Specialist is the appropriate title for you. There will be opportunities to discuss this toward the end of the interview process; however, if you wish to discuss titles earlier in the interview process, please do so with your recruiter.

Who are we?

WRA’s an employee-owned environmental consultancy. We are a tenacious team of planners, engineers, and scientists, and we aim to leave the lands we love better than we found them.

Our clients and partners hire us because we’re skilled at navigating through challenging projects involving wildlands, parks, community spaces, and infrastructure. We bring over four decades of expertise, long-standing relationships, and connections to our local communities to make sure that projects are pursued in responsible ways where both people and the environment thrive.

As an organization, we believe that independence and interdependence are not mutually exclusive. We invest in systems, processes, and employee programs to support our staff’s collective engagement and success. At the same time, we encourage our employees to operate with an ownership mindset, taking responsibility for outcomes and being true to our commitments.

WRA’s company vision is to cultivate a sustainable future where people and the environment thrive, and that effort starts first with our staff. We are committed to building a diverse, equitable, and inclusive work environment, and we have developed flexible policies, internal practices, and are investing in programs that prioritize learning and sustainability. We aim to create conditions that allow employees to prioritize their families, lead healthy and balanced lives, and to bring their authentic selves to work every day. We believe that by creating an exceptional workplace, our employees will be able to do their best work and be able to meaningfully contribute to the sustainability of the environment and the communities in which we live.

WRA is an equal opportunity employer, and we are committed to creating a diverse environment. We recruit, employ, train, compensate and promote regardless of race, religion, color, national origin, gender, sexual orientation, disability, age, veteran status, and other protected status as required by applicable law.

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

Urban Grid is a leading independent power producer (IPP) delivering reliable, utility-scale solar and storage solutions to help meet America’s unprecedented energy demand. We develop, own and operate projects that strengthen local economies through long-term partnerships and responsible land stewardship. By integrating agrivoltaics into our land management practices, we enhance soil health, support local farmers and benefit the communities we serve.

With a strong focus on execution and integrity, we are committed to being a trusted domestic energy provider and responsible corporate citizen. Urban Grid is headquartered in Houston, Texas, and operates across the United States with a growing portfolio that includes 12,000 megawatts of development assets.  We continue to maintain our optionality to co-locate with battery storage based on customer demand, ensuring flexibility and responsiveness in our energy solutions.

Since becoming an IPP in 2023, we have successfully brought five solar projects online, begun construction on three additional projects and are actively advancing one gigawatt of capacity into pre-construction. To learn more, please visit www.UrbanGridSolar.com.

Urban Grid is a portfolio company of Brookfield. one of the world’s largest owners and operators of renewable power and climate transition assets.

Job Summary

The Senior Analyst, Legal Records & Information Governance will own and administer the Company’s legal records and information management function within the Legal Department. This position will serve as the primary steward of the Company’s contract repository, transaction data rooms, corporate governance records, and other significant legal and business documents.

This is a hands-on, mid-to-senior-level individual contributor role with substantial autonomy and direct interaction with the General Counsel, executives, board members, owners, outside counsel, and cross-functional stakeholders. The Senior Analyst will ensure that records are accurate, organized, secure, consistently classified, readily retrievable, and maintained in accordance with established retention and information-governance practices.

The role will support capital markets, project finance, tax equity, M&A, corporate governance, audit, and other business activities. This position will manage the systems, records, permissions, and administrative processes that support the Legal Department and the broader organization.

Responsibilities

·         Own and administer the Company’s contract repository and other Legal Department document systems, ensuring records are complete, accurate, consistently classified, secure, and readily accessible.

·         Establish and maintain document-management standards, including metadata, taxonomies, naming conventions, tagging, folder structures, version control, and filing procedures.

·         Fulfill records and document requests from Legal, executives, board members, owners, outside counsel, auditors, lenders, investors, and other authorized stakeholders in a timely and accurate manner.

·         Set up and administer virtual data rooms for project finance, tax equity, debt financing, M&A, and other transactions, including document organization, access permissions, diligence tracking, Q&A coordination, and post-closing archiving.

·         Maintain and organize corporate governance and entity records, including organizational documents, board materials, minutes, resolutions, written consents, ownership records, and records for subsidiaries, project entities, and joint ventures.

·         Support the administration of records-retention and information-governance policies, including record classification, retention, preservation, archiving, transfer, and authorized disposition.

·         Support legal holds, audits, investigations, litigation requests, and other controlled document-production activities under the direction of counsel.

·         Protect confidential, privileged, proprietary, and sensitive information through appropriate access, filing, permission, and sharing controls.

·         Develop procedures, guides, checklists, and training materials.

·         Perform other responsibilities as assigned.

• Bachelor’s degree in business administration, legal studies, information management, or a related field, or an equivalent combination of education and relevant experience.
• Five or more years of experience in records and information management, legal operations, contracts administration, corporate governance support, transactional support, or a related function.
• Demonstrated ability to independently manage records, document systems, and competing priorities with limited supervision.
• Direct experience administering virtual data rooms (Intralinks, Datasite, SharePoint-based rooms, etc.) for project finance, tax equity, debt financing, M&A, or other complex transactions.
• Experience with contract lifecycle management, document-management, records-management, or virtual data-room platforms.
• Strong knowledge of document organization practices, including metadata, taxonomies, naming conventions, version control, records retention, and electronic filing.
• Exceptional organizational skills, high attention to detail, and ability to manage high-volume, time-sensitive requests accurately and efficiently.
• Strong written communication skills and demonstrated discretion when working with executives, board members, outside counsel, and confidential or privileged information.
• Location: Hybrid in Houston, Texas (4 days in office, Fridays remote).
• Applicants must be currently authorized to work in the United States on a full-time basis. Visa sponsorship or transfer visas, including H-1B or L-2, are not available for this position.

Urban Grid offers an exciting benefits package, including medical, dental, vision, health savings account, flexible spending account, company-paid life insurance and short-term disability, voluntary life, and long-term disability, paid paternal leave, and a retirement plan with matching contributions. Full-time position with competitive compensation package, including bonus.

Company Description

About AbbVie

AbbVie’s mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

The Senior Manager, Regulatory Affairs US & Canada Strategy Lead – Therapeutic Neurotoxins is responsible for the development and implementation of US and Canada regulatory strategic and tactical planning (RSTP) for assigned on market products or those products in development. Assures that regulatory strategies defined within the GRPT, are effectively implemented and maintained in line with changing regulatory and business needs.

The Senior Manager identifies and gathers data needed to support filings, responses to inquiries, and registration maintenance to enable commercialization of products that are developed, manufactured or distributed to meet relevant US and Canada regulatory requirements.

Responsibilities:

• Responsible for a product(s) or products with multiple driver indications within a Therapeutic Area and supports manager and/or Global Regulatory Lead (GRL) in the development & execution of the regulatory strategy.  Assigned matters may have a moderate impact on business activities and operations.
• Serves as Health Authority (HA) liaison and interfaces with FDA for meetings, teleconferences and coordinates preparation and completion of FDA meeting briefing packages and responses.
• Advise internal customers who may contribute to regulated communication on Regulatory/FDA issues including Public Affairs, Clinical Development, Legal, and others such as Commercial.
• Functions independently in negotiation and decision-making for project related issues that have cross-functional impact.
• May assist in the training of junior staff members.
• Key contributor responsible for the preparation and review of regulatory submissions consistent within US and Canada regulatory requirements and guidelines and assures complete and timely response to Health Authorities during application review.
• Supports the regulatory submission and approval process.  Broadly applies regulatory/technical knowledge of government regulations and skills across therapeutic areas.
• Recommends and implements changes to difficult projects based on knowledge and expertise, accurate interpretation of US and Canada government regulations, guidances, as well as corporate policies and management-related considerations.
• Presents pertinent regulatory information to appropriate cross-functional areas.
• Operates in compliance with regulations, company policies, procedures, and guidance in alignment with regulatory product strategy and the Quality Dossier Program (QDP).

Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required

Qualifications

• Advanced degree (e.g. PharmD, PhD, MS) or Regulatory certification with minimum 5 years Regulatory, R&D, or equivalent industry-related experience.
• Preferred: Advanced Degree and/or Certifications or direct experience with pharmaceutical regulatory activities
• Demonstrates excellent negotiation skills, problem solving skills and builds consensus.
• Demonstrates effective communication skills in written and oral channels both within Regulatory and across the organization. Able to deliver challenging messages effectively without compromising important business relationships.
• Proven skill at implementing successful affiliate regulatory strategies (US or Canada experience preferred).
• Experience working in a complex and matrix environment.
• Experience interfacing with government regulatory agencies.
• Global regulatory experience is a plus.

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. ​

• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.​

• This job is eligible to participate in our long-term incentive programs. ​

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company’s sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html

Job Title: Senior Compliance & Quality Assurance (Qualified Person) Consultant - Permanent Job Location: Sweden Job Location Type: Remote Job Contract Type: Full-time Job Seniority Level: For the past 25 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies.

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Associate/Deputy General Counsel (ET/CT Preferred)

About InMarket

Since 2010, InMarket has been the leader in 360-degree consumer intelligence and real-time activation for thousands of today’s top brands. Through InMarket’s data-driven marketing platform, brands can build targeted audiences, activate media in real time, and measure success in driving return on ad spend. InMarket’s proprietary Moments offering outperforms traditional mobile advertising by 6x.* Our LCI attribution platform, which won the MarTech Breakthrough Award for Best Advertising Measurement Platform, was validated by Forrester to drive an average of $40 ROAS for our clients.

*Source: Wordstream US Google Display Benchmarks for Mobile Media

About the Role

Reporting directly to the Chief Legal and Privacy Officer, the Deputy General Counsel will be a true second-in-command for the legal function,  an experienced, practical, and versatile lawyer who thrives in an “all hands on deck” environment, and can move fluidly from hands-on negotiations of critical commercial contracts, an analytical and practical approach to data privacy questions, and can take on ownership of important legal mandates (e.g., intellectual property, employment matters, information security, financing, insurance, legal ops) and has a demonstrated commitment to helping build the legal team by training and mentoring team members. This is a broad, high-impact role for someone who wants to be a trusted business partner and impactful leader across the company, not a narrow subject-matter specialist.

Core Areas of Responsibility

Commercial Contracts & Business Support

• Draft, review, and negotiate a wide range of commercial agreements, including customer, supplier, and partnership contracts across our business lines.

• Partner with Sales, Partnerships, and Product teams to structure deals that balance business goals with legal risk

• Maintain and continuously improve contract templates, playbooks, and negotiation protocols to speed up deal cycles across the company and efficiently deliver high-quality legal support.

• Support customer, partner, and vendor due diligence projects, especially regarding data privacy and information security

Privacy & Data Protection

• Advise on privacy and data compliance matters relevant to InMarket’s targeted advertising and ad impact measurement business, including CCPA, other state privacy laws, and ad-tech industry standards and self-regulatory frameworks

• Support the design and maintenance of our privacy policy, consent mechanisms, and data governance practices across products

• Advise on legal and regulatory considerations around the company’s use and development of AI, including data used to train or power AI/ML tools, emerging state and federal AI regulation, and responsible-AI/governance practices as the company scales its internal AI initiatives

• Monitor the evolving privacy and AI regulatory landscape and flag emerging risks or requirements to the business

• Build deeper subject-matter expertise in privacy and AI governance over time, with the opportunity to grow into a go-to resource for the company on data and AI issues

Employment & HR Support

• Serve as a day-to-day legal resource for Human Resources on employment matters, including policy guidance, terminations, leave, and accommodation questions

• Support the review and updating of employee handbooks, offer letters, and workplace policies

• Help manage employment-related risk, including guidance on investigations and disputes before they escalate

General Corporate & Governance

• Support general corporate work, including entity governance, corporate formalities, and recordkeeping

• Assist with financings, acquisitions, divestitures, and other business development or strategic transactions as they arise

• Provide legal support for corporate communications, facilities, insurance, and risk management matters

• Help evaluate and manage legal risk across new business initiatives, balancing legal exposure with commercial priorities

Legal Team Leadership & Strategic Partnership

• Act as a key advisor and thought partner to the Chief Legal and Privacy Officer and Chief Financial Officer,  helping shape legal strategy, processes, and priorities for the department

• Help build out the legal function as the company scales, including process improvement and knowledge-sharing across the team

• Mentor and support other attorneys or legal staff, with the potential to take on formal management responsibility as the department grows

Impact & Success Indicators

In your first 90 days

• Fully ramped on InMarket’s business lines, key contracts, current legal priorities, and the internal stakeholders across Sales, Product, HR, and Finance

• Taken ownership of a meaningful share of commercial contract review and negotiation, reducing turnaround time and bottlenecks for the business

• Built a working knowledge of InMarket’s current privacy posture and data practices, including how AI/ML is used across the business today

• Established trusted working relationships with the CLPO and key business partners, and identified early opportunities to streamline legal processes (templates, playbooks, intake)

In your first year

• Recognized as a go-to legal generalist and thought partner across the company, not just a contract reviewer

• Materially improved contracting velocity and consistency through templates, playbooks, and clearer processes

• Established InMarket as proactively (not reactively) managing privacy and AI-related legal risk, with clear internal guidance on responsible AI use and data governance

• Taken on visible ownership of at least one major cross-functional initiative (e.g., a financing, acquisition, reorg, or significant compliance project)

• Demonstrated readiness for expanded scope, whether that’s formal management of other attorneys/legal staff or deeper specialization in a growth area like privacy/AI, depending on how the department evolves

We’re Looking For Someone With

• A JD from an ABA-accredited law school and active bar admission in the jurisdiction where you reside.

• Significant in-house experience as a generalist, with demonstrated ability to work confidently across multiple legal disciplines (commercial contracts, privacy, employment, general corporate).

• Eagerness to develop additional competencies in privacy, intellectual property, commercial contracts, and employment law. Genuine curiosity about the evolving field of privacy law is especially welcome.

• High personal standards of excellence and ethics. You act with discretion, strict confidentiality, and excellent judgment when dealing with critical, sensitive, or high-stakes matters.

• Flexibility and adaptability. You appreciate working across numerous teams and diving into multiple challenges at any given time. You evaluate and address legal risks while maintaining a business-minded approach and seeking practical solutions.

• Drive, tenacity, and a get-it-done attitude matched only by unwavering ethics, integrity, and trustworthiness. You are well-equipped with relevant experience, operate with low ego, and are committed to getting the job done and done well.

• An interest in InMarket’s business, values, and the evolving landscape of ad tech, data, and consumer intelligence.

Compensation & Benefits

For candidates in California, Colorado, New York City, Illinois, Minnesota, New Jersey, Vermont, and Massachusetts, the Targeted Base Salary Range for this role is $240,000 to $290,000.

Actual salaries will vary depending on factors including, but not limited to, work experience, specialized skills and training, performance in the role, business needs, and job requirements. Base salary is subject to change and may be modified in the future. Base salary is just one component of InMarket’s total rewards package, which may also include bonuses, equity, and benefits. Ask your recruiter for more information!

Additional perks and benefits:

• Competitive salary and stock options

• Flexible vacation / Unlimited PTO (within reason)

• Medical, dental, and Flexible Spending Account (FSA)

• Company Matched 401(k)

• Paid Paternity & Maternity Leave

• Agile Development Program for continued learning and professional development

Equal Opportunity Employer

At InMarket, diversity is not just a value; it’s the very essence of who we are. It’s about recognizing and celebrating the unique perspectives each of us brings, from our colleagues to the communities we serve. We are committed to embracing the full spectrum of backgrounds, beliefs, abilities, and life experiences, knowing that this diversity strengthens us. At InMarket, our commitment to Diversity, Equity, and Inclusion means valuing each individual’s unique contributions. Together, we thrive.

InMarket is an Equal Opportunity Employer (EOE). Qualified applicants are considered for employment without regard to age, race, color, religion, sex, national origin, sexual orientation, disability, or veteran status.

Privacy Notice for California Job Applicants: https://inmarket.com/ca-notice-for-job-applicants/

All applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time.