Regulatory

Regeneron Pharmaceuticals, Inc.

Compliance Specialist, External Manufacturing

**Build our future together:**

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking to fill a Compliance Specialist position within the External Manufacturing team. This role is responsible for operations support and compliance related activities for the manufacturing of Regeneron products.

**When & where:**

- Location: East Greenbush, New York, United States
- Work schedule: Monday-Friday, 8am-4:30pm

**Discover your role:**

- Lead and manage change controls, SCARs, SCNs, NPCs, and CAPAs
- Review and maintain procedures, polices and other instructional documents with a focus on continuous improvement
- Maintain knowledge of current good manufacturing practices (cGMPs)
- Support both internal and external inspection and audit readiness activities
- Responsible for periodic reviews of Drug Product Manufacturing documentation and records to assess for compliance with established quality standards, policies and procedures
- Maintain required training status on Regeneron specific work instructions and SOPs
- Continuous process improvement implementation

**This role requires:**

- BS/BA in scientific field and the following amount of related experience in cGMP manufacturing operations (clinical and/or commercial for each level:
  - Associate Specialist 0-2 years
  - Specialist 2+ years
  - Sr Specialist 5+ years
  - Level will be determined based on experience
- Knowledge of drug product manufacturing from formulation through the final package
- Basic knowledge of regulatory compliance inclusive of cGMP, FDA regulations, familiarity with ICH guidelines and EU regulations
- Proficient in Veeva, Opstrakker, Excel, PowerPoint, Visio, Word, etc. in addition to experience working within shared work environments
- Strong interpersonal, written and oral communication skills, with an emphasis on technical writing
- Exhibits confidence, has a high emotional IQ, and has strong interpersonal, written and oral communication skills for providing team updates
- Shows resiliency and flexibility in the face of challenges and adversarial situations
- Understands and listens to team members and stakeholders needs while supporting productive team environments toward a common objective
- Experience in collaborating with CMOs/CROs is preferred

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit [https://careers.regeneron.com/en/working-at-regeneron/total-rewards/](<https://careers.regeneron.com/en/working-at-regeneron/total-rewards/>). For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

**Salary Range (annually)**

$62,355.00 - $128,700.00

New York

Manager, CMC Regulatory Affairs - Biologics

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Manager, CMC Regulatory Affairs - Biologics to join our CMC Regulatory Affairs team, supporting our biologics portfolio in an on-site work model. In this role, you will lead regulatory strategy and regulatory compliance activities across development, submissions, and post-market programs while collaborating with Global Regulatory Affairs and CMC collaborators.

**This position offers the opportunity to work with a fast-growing, science-driven organization, which makes a meaningful difference for patients worldwide.**

**When & where:**

Location: Rensselaer, New York

Work model: On-site

**Discover your role:**

- Lead CMC regulatory strategies for assigned biologic products.
- Support CMC development through early phase, submission, and post-market activities.
- Assess changes and deviations for regulatory impact and filing requirements.
- Review regulatory filings for compliance with applicable regulations and guidelines.
- Support regulatory authority interactions, including meetings and information request responses.
- Develop Working Instructions, SOPs, and Reviewers Guides to improve consistency.
- Identify regulatory process gaps and recommend efficiency improvements.
- You translate ambiguity into actionable steps and build alignment across teams.

**This role requires:**

- Bachelors degree with 6+ years, or advanced degree with 3+ years, in pharmaceutical, biotechnology, or Health Authority settings.
- 2-4 years of CMC Regulatory Affairs experience with worldwide regulations.
- Strong understanding of global CMC Regulatory Affairs requirements.
- Experience delivering CMC sections of marketing authorizations, CTA/INDs, and post-approval submissions.
- Experience supporting biologic products preferred.
- Experience engaging with FDA or other regulatory authorities preferred.
- Strong communication, negotiation, strategic thinking, and problem-solving skills.
- Ability to build cross-functional partnerships, manage competing priorities, and deliver results in dynamic environments.
- Ability to support training activities and proactively address technical or regulatory knowledge gaps.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit [https://careers.regeneron.com/en/working-at-regeneron/total-rewards/](<https://careers.regeneron.com/en/working-at-regeneron/total-rewards/>). For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

**Salary Range (annually)**

$108,000.00 - $176,000.00

Manager Combination Products - Regulatory Affairs

**Build our future together:**

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Manager, Regulatory Affairs - Combination Products to join our Regulatory Affairs team, supporting our combination product business area in an onsite work model. In this role, you will support global combination product development, regulatory submissions, and post-market activities while collaborating with Regulatory Affairs, Manufacturing, Quality, and combination product stakeholders. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

**When & where:**

Rensselaer, New York

Work model: Onsite, 5 days per week

**Discover your role:**

Support combination product development from early phase through post-market activities.

Review regulatory filings including INDs, BLAs, MAAs, annual reports, and supplements.

Develop design control documentation and quality systems for combination products.

Assess changes and deviations for regulatory impact and submission requirements.

Support regulatory authority meetings, responses, and inspections.

Create SOPs, Working Instructions, and Reviewers Guides.

Identify process gaps and support regulatory intelligence activities.

You translate ambiguity into action and build effective stakeholder partnerships.

This role requires:

Bachelors degree with 6+ years related experience, or advanced degree with 3+ years related experience in pharmaceutical or biotechnology, settings.

2-4 years of CMC Regulatory Affairs experience supporting worldwide regulations.

Strong understanding of global CMC Regulatory Affairs requirements, including combination products and human factors.

Experience delivering marketing authorizations, CTA/INDs, and post-approval submissions.

Experience supporting biologics and combination products preferred.

Experience engaging with FDA or other regulatory authorities preferred.

Ability to assess regulatory impact, support compliance activities, and mentor junior staff.

Strong communication, negotiation, strategic thinking, problem-solving, prioritization, and cross-functional collaboration skills.

Ability to support training activities and proactively address technical or regulatory knowledge gaps.

We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit [https://careers.regeneron.com/en/working-at-regeneron/total-rewards/](<https://careers.regeneron.com/en/working-at-regeneron/total-rewards/>). For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

**Salary Range (annually)**

$108,000.00 - $176,000.00

Manager, CMC Regulatory Affairs - Biologics

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases.

We are seeking a Manager, CMC Regulatory Affairs - Biologics to join our CMC Regulatory Affairs team, supporting our biologics portfolio in an on-site work model.

In this role, you will lead regulatory strategy and regulatory compliance activities across development, submissions, and post-market programs while collaborating with Global Regulatory Affairs and CMC collaborators.

**This position offers the opportunity to work with a fast-growing, science-driven organization, which makes a meaningful difference for patients worldwide.**

**When & where:**

Location: Rensselaer, New York

Work model: On-site

**Discover your role:**

- Lead CMC regulatory strategies for assigned biologic products.
- Support CMC development through early phase, submission, and post-market activities.
- Assess changes and deviations for regulatory impact and filing requirements.
- Review regulatory filings for compliance with applicable regulations and guidelines.
- Support regulatory authority interactions, including meetings and information request responses.
- Develop Working Instructions, SOPs, and Reviewers Guides to improve consistency.
- Identify regulatory process gaps and recommend efficiency improvements.
- You translate ambiguity into actionable steps and build alignment across teams.

**This role requires:**

- Bachelors degree with 6+ years, or advanced degree with 3+ years, in pharmaceutical, biotechnology, or Health Authority settings.
- 2-4 years of CMC Regulatory Affairs experience with worldwide regulations.
- Strong understanding of global CMC Regulatory Affairs requirements.
- Experience delivering CMC sections of marketing authorizations, CTA/INDs, and post-approval submissions.
- Experience supporting biologic products preferred.
- Experience engaging with FDA or other regulatory authorities preferred.
- Strong communication, negotiation, strategic thinking, and problem-solving skills.
- Ability to build cross-functional partnerships, manage competing priorities, and deliver results in dynamic environments.
- Ability to support training activities and proactively address technical or regulatory knowledge gaps.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way!

We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits.

For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit [https://careers.regeneron.com/en/working-at-regeneron/total-rewards/](<https://careers.regeneron.com/en/working-at-regeneron/total-rewards/>). For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

**Salary Range (annually)**

$108,000.00 - $176,000.00

CMC Product Quality Compliance Specialist (PQR)

**Build our future together:**

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a **CMC** **Product Quality Compliance Specialist** to support our Product Quality Review (PQR) activities. In this role, you will be responsible for being a quality representative for product and distribution compliance of Regenerons commercial programs including support with the product quality reviews (PQR). This role supports the development, coordination and ownership of the quality and compliance elements of the life cycle strategy, including ownership of the global regulatory change management implementation plan, end-to-end optimization efforts and overseeing product management activities. Works collaboratively with CMC team members, alliance partners, collaborators and CMOs to ensure continuity of supply, consistency within and across programs, supply strategy alignment across functions, and compliance process efficiency.

This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

**When & where:**

- Location: Rensselaer, New York, United States
- Work model: Monday-Friday, 8:00 AM - 4:30 PM

**Discover your role:**

- Oversees the global change management implementation plan
- Supports the evaluation of impact of proposed process changes, deviations and CAPAs on the end-to-end supply chain.
- Oversees the coordination and generation of the annual PQRs and yearly biologic product reports (YBPR).
- Assesses quality-related information to detect trends and works with subject matter experts to determine the need for actions required in response to those trends
- Ensures drug supply distribution compliance with all aspects of global regulatory filings to ensure stable supply positioning.
- Interacts with global regulatory authorities in support of the CMC activities during Agency inspections.
- Collaborates cross-functionally to support regulatory release process and inventory review.
- Execute relationship management with other areas of Regulatory, Quality, Manufacturing, and Supply organizations to support product distribution.
- Develops procedures and systems for enhanced tracking of change controls and global regulatory submissions/approvals.
- Support launch readiness and distribution compliance through ensuring appropriate GMP source documentation is in place to support regulatory activities, and launch material is aligned with the applicable regulatory dossiers.
- Responsible for providing writing and strategy support in communications to regulatory agencies including product deviation reports (BPDR, QDR, PDR, etc.), clinical notice of events and agency inspection responses in collaboration with CMC RA, QA, and SMEs as applicable.
- Facilitates the commercial and registration requests (CARRs) process in collaboration with CMC PM, CMC RA, IMT and SMEs as applicable.

**This role requires:**

Requires BS/BA in Chemistry, Biology or related field.

- Assoc QA Specialist: minimum of 0- 2 years relevant experience. with relevant experience or equivalent combination of education and experience, preferably pharmaceutical or medical device, including some supervisory and/or leadership experience

- Specialist: minimum of 2 years relevant experience in pharmaceutical or medical device, including some supervisory and/or leadership experience or equivalent combination of education and experience.

- Sr Specialist: minimum 5 years relevant experience in pharmaceutical or medical device, including some supervisory and/or leadership experience or equivalent combination of education and experience.

Level is determined based on qualifications relevant to the role.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit [https://careers.regeneron.com/en/working-at-regeneron/total-rewards/](<https://careers.regeneron.com/en/working-at-regeneron/total-rewards/>). For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

**Salary Range (annually)**

$67,400.00 - $110,000.00

Senior Manager, Health Economics & Outcomes Research (HEOR)- Real-World Data and Analytics,

**Build our future together:**

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Senior Manager, Real-World Data and Analytics (RWDnA) will support the generation of real-world evidence (RWE) in oncology by delivering data-driven insights through the analysis of real-world data (RWD). The individual will contribute to query/protocol/statistical analysis (SAP) development and execute analyses of RWD to support the generation of RWE to address research questions. The successful candidate will conduct hands-on programming on internal RWD assets, support publication activities, and participate in vendor management.

This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

**When & where**:

Location: Sleepy Hollow, NY

Work model: On-site 4 days/week

**Discover your role**:

Contribute to the development of RWE queries, protocols, and statistical analysis plans (SAPs) within oncology

Translate analytic findings into clear insights and communicate them directly to project teams

Support end-to-end RWE query and study delivery, including hands-on programming and quality control of analytic code

Evaluate and identify appropriate real-world data sources to address specific research questions

Contribute to scientific communications, including abstracts, posters, manuscripts, and internal presentations

Support senior team members in coordinating activities with external analytics vendors and research partners

**This role requires**:

Doctoral degree in a quantitative field focused on the application of data science to healthcare data with 2+ years of hands-on programming experience; or a Master's degree in a related field with 4+ years of hands-on programming experience

Hands-on experience with real-world data sources such as large-scale administrative claims data (e.g., Optum, Medicare, Norstella) and electronic health records (EHRs)

Experience in immunology research

Advanced programming capabilities using SAS and R

Proficiency in statistical methodologies including survival analysis, propensity score methods, and generalized linear models.

Experience with machine learning approaches applied to real-world data

Excellent written and verbal communication skills

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit [https://careers.regeneron.com/en/working-at-regeneron/total-rewards/](<https://careers.regeneron.com/en/working-at-regeneron/total-rewards/>). For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

**Salary Range (annually)**

$150,500.00 - $245,500.00

Senior Manager, Health Economics and Outcomes Research Epidemiology - Cardiovascular, Metabolic,

**Build our future together:**

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Senior Manager, Epidemiology for our Health Economics and Outcomes Research team to support our Cardiovascular, Metabolic and Rare disease programs. In this role, you will generate real-world evidence that influences the development and commercialization of innovative oncology therapies while collaborating with HEOR colleagues and key collaborators.

This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

**When & where**:

Location: Sleepy Hollow, NY

Work model/flexibility: On-site 4 days/week

**Discover your role:**

Generate high-quality observational research using diverse real-world data sources to support development and commercial strategies

Evaluate and implement emerging design and analytic methods to strengthen our RWE capabilities

Synthesize and critically assess scientific evidence for regulatory and payor submissions, press releases, and internal business needs

Support global HTA and payor submissions with epidemiology and RWE inputs for value dossiers and reimbursement packages

Provide technical expertise to clinical development and evidence generation, and external control arms and hybrid approaches

Stay current with evolving regulatory and payor expectations for RWE and guide internal teams on the implications

Participate in epidemiologic design discussions in a peer review forum

Drive projects forward with a growth mindset, proactively identifying solutions and managing priorities

**This role requires:**

Doctoral degree in epidemiology or a related subject area (e.g., health services research, public health), plus at least 2 years of experience across academia, pharma/biotech, or consulting

Hands-on experience drafting technical design documents, study protocols and/or statistical analysis plans using real-world data (claims, HER, registries), with a record of peer-reviewed publications

Excellent communication skills, with the ability to translate complex designs and findings into clear, actionable insights for diverse audiences

Experience conducting epidemiology and RWE research in oncology, including familiarity with cardiovascular, metabolic, or rare diseases is preferred

Experience applying advanced analytical methods to large healthcare datasets, including causal inference, bias assessment, and robust estimation is preferred

Familiarity with global HTA and payor evidence needs, value and reimbursement strategies are preferred

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit [https://careers.regeneron.com/en/working-at-regeneron/total-rewards/](<https://careers.regeneron.com/en/working-at-regeneron/total-rewards/>). For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

**Salary Range (annually)**

$150,500.00 - $245,500.00

Associate Director Patent Attorney

**Build Our Future Together**

The Associate Director, Patent Attorney will act as legal counsel on matters related to the development, protection, and management of Regenerons valuable intellectual property pertaining to its manufacturing. The role will be responsible for patent activities relating to manufacturing and bioprocessing at all stages of the development pipeline including cell line technologies, purification, formulations, assay and media development. This position will partner closely with our world-class scientists and manufacturing development leaders around key strategies for our rapidly growing patent portfolio, patent filings, trade secret protection, and patent actions.

**When & where:**

- Work Location: Tarrytown, NY
- Work model/flexibility: 4 days per week on site

**Discover your role:**

- Identifying, capturing and prosecuting new inventions relating to manufacturing and bioprocessing; Preparing and prosecuting global patent applications relating to all aspects of manufacturing & bioprocessing including cell development, cell culture, purification, assay development, formulation, packaging and delivery; Leading outside counsel on various projects as appropriate;
- Conducting patent landscape overviews, freedom-to-operate analyses, validity assessments and patentability assessments in relation to Regeneron pipeline products, and presenting the results and analyses to senior members of the Law Department and senior management;
- Leading US and foreign administrative patent actions (e.g., oppositions, third party observations, inter partes reviews, etc.);
- Supporting due diligence projects, agreements and other transactional work, administrative initiatives, and policy questions.
- Advising on emerging legal issues, including monitoring and reviewing case law and legislative developments.
- Possess strong interpersonal skills and the ability run multiple projects against competing priorities.
- Excel at handling a large and sophisticated docket with minimal direction.
- Have exceptional communication skills, including presentation, interpersonal, writing and conflict resolution.

**This role requires:**

- Ph.D. in the life sciences (e.g., biochemistry, molecular biology, cell biology, or related fields)
- Juris Doctorate from an accredited law school
- Admitted to practice before the USPTO and licensed to practice law in at least one state (member of the NY bar or eligible for in-house licensure in NY)
- 5+ years of proven experience in a law firm setting (with or without corporate law department experience) preparing and prosecuting patent applications in the biological arts.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit [https://careers.regeneron.com/en/working-at-regeneron/total-rewards/](<https://careers.regeneron.com/en/working-at-regeneron/total-rewards/>). For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

**Salary Range (annually)**

$176,100.00 - $287,300.00

Quality Compliance Specialist

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. Regeneron is currently looking for a Quality Compliance Specialist to join our Quality Assurance team. This position will focus on internal change controls. The Quality Compliance Specialist ensures quality and compliance to cGMPs, internal, external, and international requirements with respect to change control activities. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

**When & where:**

- Location: Rensselaer, New York, United States
- Work model: Monday-Friday, 8am-4:30pm

**What you'll do:**

- Review, assess, edit, and approve change control documentation to ensure compliance with quality, regulatory, and SOP requirements
- Facilitate cross-functional meetings, offering guidance and consultation to change control owners throughout the process
- Build strong relationships with end users, serving as a go-to resource on standard change control processes
- Partner with quality assurance colleagues and system end users to identify, develop, and implement continuous improvements to the change control system, processes, and related procedures
- Interpret compliance and regulatory requirements, translating them into departmental systems, procedures, and documentation
- Support regulatory and customer audits as a subject matter expert on change control
- Apply strong working knowledge of biotech/pharmaceutical quality systems, including cGMP, FDA regulations, and familiarity with ICH guidelines and global regulatory standards
- Analyze and interpret process and systems information, technical procedures, reports, and regulations to support sound decision-making in a cGMP environment
- Leverage strong digital proficiency in MS Word, Excel, and PowerPoint; experience with Veeva/QMS is a plus

**Lets find out if were a fit**:

- Requires B.S in life sciences or related field; may substitute proven experience for education requirement
  - Associate Quality Compliance Specialist: 0-2+ years of experience
  - Quality Compliance Specialist: 2+ years of experience
  - Level will be determined based on experience

**Thrive today. Grow tomorrow.**

- Student loan paydown program & tuition reimbursement
- Family care benefits
- Relocation assistance
- Inclusion, culture and well-being programs (including physical & mental health)

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit [https://careers.regeneron.com/en/working-at-regeneron/total-rewards/](<https://careers.regeneron.com/en/working-at-regeneron/total-rewards/>). For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

**Salary Range (annually)**

$67,400.00 - $110,000.00

2027 Co-op Cell Medicines Research & Development

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. Regeneron is currently seeking multiple 2027 Co-ops to join our Regeneron Cell Medicines (RCM) team, Regeneron's cell therapy unit developing next-generation T-cell therapies for cancer.

These positions offer the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

**When & where:**

**Location:** Cambridge, MA / Seattle, WA

**Timeframe:** Our Co-op positions are full-time and onsite from January-August (Spring-Summer), May/June-December (Summer-Fall), and August-December (Fall).

**Pay**: Intern and Co-op pay ranges are determined by level of education (year in school) and degree program. The hourly rate range for these locations is: $17.90-$50.90 per hour.

**What youll do:**

- Support in vitro safety and efficacy testing of cell therapy candidates

- Develop tumor antigen expression and flow cytometry methods

- Contribute to viral-vector production and process development for cell engineering

- Support high-throughput protein production activities

- Contribute to analytical method development supporting Good Manufacturing Practice (GMP) manufacturing

- Support digital-transformation initiatives for manufacturing operations

- Document experimental procedures and results

- Collaborate with scientists across the cell therapy team

**Relevant majors:** Biology, Biochemistry, Biomedical Engineering

**Lets find out if were a fit**:

- Must be enrolled in, or accepted to, an academic program pursuing an Undergraduate or Graduate degree (and be returning to school the semester following the position or graduating after the position)
- Must be able to commit to 40 hours per week from January-August, May/June-December, or August-December
- Demonstrated leadership in areas such as campus activities, clubs, sports, current or previous work, or within the community preferred
- Cumulative GPA of 3.0 or higher preferred

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit [https://careers.regeneron.com/en/working-at-regeneron/total-rewards/](<https://careers.regeneron.com/en/working-at-regeneron/total-rewards/>). For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Massachusetts

Associate Manager Regulatory Affairs

**Build our future together:**

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking an Associate Manager, Regulatory Affairs to join our UK regional team, supporting our UK and Ireland markets in a hybrid setting. In this role, you will support marketing authorisations and licence maintenance across therapeutic areas while collaborating with local, regional and global colleagues. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

**When & where:**

Uxbridge (Hybrid)

**Discover your role:**

- Prepare, compile and lead timely marketing applications and post-approval variations through Medicines and Healthcare products Regulatory Agency (MHRA) pathways.
- Support submission strategies, negotiate with MHRA partners and communicate implementation to UK and Ireland teams.
- Author, review and manage module documents, responses and UK Paediatric Investigational Plans alongside pre-submission and scientific advice meetings.
- Support UK labelling, artwork and related meetings alongside UK/Ireland promotional and additional risk minimisation material reviews.
- Represent regulatory across commercial, medical, patient safety, quality and global submissions teams within the European Union (EU) regional team.
- Maintain local regulatory knowledge and UK/Ireland compliance while supporting UK and EU clinical trial applications and inspections.
- Develop best-practice user guides, work instructions and standard operating procedures through departmental initiatives.
- You bring a proactive, collaborative approach to regulatory challenges.

**This role requires:**

- Bachelors or advanced degree in life sciences, pharmacy or a related scientific field.
- UK/Ireland regulatory experience, approximately up to two years, managing Type II clinical variations and approvals through MHRA pathways.
- Experience handling post-Brexit UK applications and regulatory pathways.
- Knowledge of clinical trial requirements, procedures and EU medicines development.
- Regulatory database proficiency and ability to manage parallel submissions against firm deadlines and changing priorities.
- Strategic thinking, commercial awareness, excellent written/verbal communication and ability to foster strong global matrix teamwork.
- UK rare disease therapeutic-area experience preferred.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit [https://careers.regeneron.com/en/working-at-regeneron/total-rewards/](<https://careers.regeneron.com/en/working-at-regeneron/total-rewards/>). For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Other Non-US

Manager CMC Regulatory Affairs

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Manager, CMC Regulatory Affairs - Biologics to join our CMC Regulatory Affairs team, supporting our biologics portfolio in an on-site work model.

In this role, you will lead regulatory strategy and regulatory compliance activities across development, submissions, and post-market programs while collaborating with Global Regulatory Affairs and CMC collaborators.

This position offers the opportunity to work with a fast-growing, science-driven organization, which makes a meaningful difference for patients worldwide.

**When & where:**

Location: Warren, New Jersey

Work model: Hybrid - 4 days a week on-site

**Discover your role:**

- Lead CMC regulatory strategies for assigned biologic products.
- Support CMC development through early phase, submission, and post-market activities.
- Assess changes and deviations for regulatory impact and filing requirements.
- Review regulatory filings for compliance with applicable regulations and guidelines.
- Support regulatory authority interactions, including meetings and information request responses.
- Develop Working Instructions, SOPs, and Reviewers Guides to improve consistency.
- Identify regulatory process gaps and recommend efficiency improvements.
- You translate ambiguity into actionable steps and build alignment across teams.

**This role requires:**

- Bachelors degree with 6+ years, or advanced degree with 3+ years, in pharmaceutical, biotechnology, or Health Authority settings.
- 2-4 years of CMC Regulatory Affairs experience with worldwide regulations.
- Strong understanding of global CMC Regulatory Affairs requirements.
- Experience delivering CMC sections of marketing authorizations, CTA/INDs, and post-approval submissions.
- Experience supporting biologic products preferred.
- Experience engaging with FDA or other regulatory authorities preferred.
- Strong communication, negotiation, strategic thinking, and problem-solving skills.
- Ability to build cross-functional partnerships, manage competing priorities, and deliver results in dynamic environments.
- Ability to support training activities and proactively address technical or regulatory knowledge gaps.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits.

For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit [https://careers.regeneron.com/en/working-at-regeneron/total-rewards/](<https://careers.regeneron.com/en/working-at-regeneron/total-rewards/>). For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

**Salary Range (annually)**

$108,000.00 - $176,000.00

New Jersey

Senior Manager Regulatory Affairs

**Build our future together:**

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Senior Manager, Regulatory Affairs to join our Regulatory Affairs team, supporting our Canadian projects in a hybrid setting. In this role, you will develop globally aligned regulatory strategies throughout product development while collaborating with global regulatory and product teams. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

**When & where:**

Toronto (Hybrid)

**Discover your role:**

- Serve as primary Canadian authority contact, leading meetings for assigned projects.
- Manage timely Health Canada clinical trial, marketing application and post-approval submissions.
- Develop high-quality, globally aligned regulatory strategies throughout relevant product development stages.
- Represent Regulatory Affairs on cross-functional teams.
- Ensure Canadian regulatory and local standards compliance; monitor Health Canada policy, regulation and guidance changes, providing comments.
- Develop local labelling and patient information; approve promotional and non-promotional materials against regulatory requirements.
- Support Health Canada Drug Establishment License activities and local/global process development.
- You bring a collaborative mindset to regulatory challenges.

**This role requires:**

- Scientific bachelors degree; advanced degree preferred.
- 68 years regulatory experience leading submissions and obtaining clinical trial application, New Drug Submission and post-market submission approvals.
- Experience leading face-to-face Health Canada meetings and new product launches.
- Strategic thinking and clinical advice based on local requirements.
- Problem-solving, multitasking and prioritisation abilities.
- Excellent verbal, written and interpersonal communication.
- Collaboration in an innovation-focused matrix environment.
- French and English bilingualism is an asset.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit [https://careers.regeneron.com/en/working-at-regeneron/total-rewards/](<https://careers.regeneron.com/en/working-at-regeneron/total-rewards/>). For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

**Salary Range (annually)**

$121,275.00 - $171,275.00

California

Eli Lilly and Company

Senior Director, Counsel, Diagnostics & Medical Devices (USA Remote Role)

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

**Senior Director, Counsel, Diagnostics & Medical Devices**

**Key Objectives/Deliverables:**

Provide strategic and solutions-oriented counseling to the Neuroscience Business Unit and other Lilly business units as assigned, on diagnostic and device issues related to their commercial strategy (e.g., lab-developed tests, in vitro diagnostics, imaging agents, medical devices, and software/digital health).

This attorney will counsel business unit marketing, medical affairs, and related teams on commercial legal matters related to diagnostics, including FDA labeling and advertising requirements, the Anti-Kickback Statute and its safe harbors, the False Claims Act, antitrust, unfair competition law, consumer protection, data rights and privacy, FTC commercial law, and business transactions (including OUS) — with particular depth in fraud and abuse, promotional, and antitrust matters.

Depending on the business unit and programs assigned, additional subject matter may include laws and regulations pertaining to pharmaceutical promotion and other medical device and digital health matters.

In this role, this attorney will work collaboratively with legal colleagues in other areas, business units, and affiliates, and must be proactive and adept in providing practical counsel in a fast-paced, dynamic, and innovative environment.

**Responsibilities:**

Activities in this role may include the following:

- Providing legal counsel and education on FDA labeling and promotional matters for diagnostic products and medical devices, as well as pharmaceuticals

- Providing diagnostics and device-related fraud and abuse, promotional, and antitrust counsel to the Neuroscience Business Unit and potentially across multiple business units, as assigned

- Collaborating with sales and marketing colleagues to advise on device or diagnostic-related patient support and consumer programs consistent with healthcare fraud and abuse laws

- Educating business partners on potential legal implications of proposed marketing tactics related to diagnostics and medical devices

- Advising on potential legal implications related to interactions with third parties relevant to diagnostics and devices, including diagnostics companies and software/digital health companies

- Counseling on sponsored testing programs

- Participating as a core member of leadership teams responsible for diagnostics- and device-related brand and/or product strategies

**Basic Requirements:**

- Bachelor's degree and JD.

- Licensed to practice law in at least one of the 50 States

- Minimum of 7 years of relevant legal experience, practicing as a member of a law firm with a nationally recognized practice in medical devices and in vitro diagnostics, in-house at a medical device, laboratory or diagnostics company law department, in-house in a pharmaceutical or biotechnology company's law department, or a combination of the foregoing. In-house experience is preferred.
- *Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.*

**Additional Skills and Expertise:**

- Deep knowledge and understanding of FDA laws and regulations pertaining to diagnostics and medical devices (e.g., Medical Device Amendments of 1976 to the FDCA, CLIA, state laws)

- Demonstrated knowledge of device and pharmaceutical marketing laws and regulations as generally practiced by innovative, multinational companies

- Demonstrated experience with fraud and abuse, promotional, and antitrust matters

- Experience evaluating sponsored testing programs for compliance

- Experience evaluating scientific communications and applying principles for communicating truthful and non-misleading scientific information

- Familiarity or experience supporting global marketing and commercialization of diagnostics or pharmaceuticals is a plus

- Ability to manage multiple priorities in a fast-paced and evolving environment

- Demonstrated ability to assess and help business colleagues manage risks in a highly regulated environment
- Sound judgment and issue-spotting ability

- Strong interpersonal skills and ability to partner well with others

- Committed to teamwork and collaboration

- Excellent oral and written communication skills, with a demonstrated ability to present complex information accurately and concisely to influence others at all levels of management

- Fluency in technology and appetite for applying technological solutions to simplify work and improve efficiency in the delivery of legal services

**Other Information:**

Some travel required (circa 10% - US and possibly limited international).

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ([https://careers.lilly.com/us/en/workplace-accommodation](<https://careers.lilly.com/us/en/workplace-accommodation>)) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$199,500 - $321,200

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

\#WeAreLilly

Indiana

Director - Clinical Research Physician - GPS Medical

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

Clinical Research Physician, GPS Medical

**Purpose**

The Clinical Research Physician (CRP) in GPS Medical has responsibilities associated with the development, management, execution, and oversight of all aspects of the safety program for one (or more) asset(s) throughout the product(s’) life cycle. This individual plays a major role in coordinating technical functions within GPS to facilitate these responsibilities. The individual is accountable for collaborative contributions and partnership with the integrated development or product team to deliver on these safety commitments while demonstrating GPS expertise and leadership.

The CRP is the Lilly GPS Medical representative for both internal and external stakeholders regarding a product or developmental therapeutic agent, interacting as prescribed in corporate guidelines, standards, and policies. Individualized responsibilities for a particular product or project will be discussed and agreed at an individual level.

**Primary Responsibilities**

This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Not all listed responsibilities will be applicable to all GPS Medical CRP roles.

1. Key GPS Medical Activities and Safety Oversight

▪ Provides GPS Medical leadership and ensures proactive pharmacovigilance (PV) for assigned product(s):

i. In early phase development, performs and/or contributes to medical review of individual case safety reports for completeness and accuracy, providing company causality assessment and requests for follow up, if needed.

ii. Provides medical oversight of surveillance activities, safety signal decisions and risk management actions to be taken, including communication and/or escalation to appropriate internal or external stakeholders (e.g., GPS leadership, governance committees, development teams, Regulators)

iii. Monitors various safety activities for impact to Core Safety Information and Core Risk Minimization activities i

v. Builds collaborative working relationships to ensure full cooperation; guides effective and efficient drug development, and ensures high-quality medical evaluation of safety data

v. Responsible for the oversight and actions related to regulatory queries on safety-related topics

▪ Acts as the GPS Medical lead at the time of acquisitions and integrations of new companies/assets, partnering with internal and external stakeholders to ensure seamless continuity of safety surveillance activities.

▪ Demonstrates advanced knowledge of safety concepts, per ICH, US and international regulation/guidelines and GxP.

▪ Synthesizes complex data into actionable insights and translates technical issues into strategic discussions

2. Acts as the Lilly GPS Medical Representative for both internal and external stakeholders, interacting as prescribed in corporate guidelines and policies.

▪ Builds strong relationships with key stakeholders, representing and championing the role of safety in the organization (including):

i. Product Team Leaders and Business Unit Leadership

ii. Regulatory (including Device and CMC regulatory)

iii. Affiliate Medical Leadership/Clinical Research Physicians

iv. COE and Discovery and Clinical Research

v. External Opinion Leaders

▪ Reviews and comments on external regulatory policy and trends affecting Global Patient Safety.

▪ Represents GPS Medical in inspection and audit activities for assigned program(s)

▪ May serve on safety advisory hub committees and/or consultative cross-functional bodies providing input and guidance to clinical development teams on select safety topics

▪ May serve as a member of the Quality-GPS (AE/PC and Device) safety surveillance teams evaluating aggregate product complaint/adverse event data for potential manufacturing quality related safety signals

3. Product Safety Assessment

• Provide the sound and timely medical assessment decision making for the safety questions based on current medical and scientific data in collaboration with cross-functional partners for the following:

i. Product Safety Assessments (PSAs), Health Hazard Evaluations (HHEs), and other risk assessment documentation

ii. Device design, development, risk management, and periodic reporting

iii. CMC development, manufacturing changes, CMC submissions and CMC regulatory requests,

iv. Company anticounterfeiting activities, product shortage evaluations, quality triage escalation activities and regulatory reporting.

▪ Provide clinical evaluation of individual adverse events for possible manufacturing-related root cause for Lilly products

▪ Responsible for appropriate implementation of PSA/HHE process with manufacturing and/or marketing partners.

▪ Prepare medical complaints in response to signals identified during AE/PC and Device Surveillance.

▪ Review and approve/reject manufacturing investigation results in response to medical complaints, including escalation as needed for any identified manufacturing related safety issues.

▪ Proactive monitoring to evaluate for unanticipated safety impacts related to deviations addressed by HHEs

4. People Management

▪ Foster and support a collaborative working environment that maintains a Team Lilly culture focused on inclusion, innovation, acceleration, and delivery

▪ Recruit, mentor, develop, and retain top clinical, scientific, and drug development talent, including clinical research physicians, clinical research scientists, and pharmacoepidemiologists.

▪ Assures staff comply with company policies and procedures

5. Understand and support the QPPV role

▪ Understanding the roles and responsibilities of the European Union Qualified Person (QPPV).

▪ Ensure support is provided to enable the Qualified Person to fulfill all the Qualified Person legal responsibilities.

6. Training, Coaching, Mentoring

▪ Provide training, coaching and mentorship demonstrating effective PV strategies and sharing experience and knowledge to further advance the goals of the GPS department and wider enterprise.

▪ Maintain compliance with Lilly Red Book and corporate policies, Lilly Research Laboratories and Global Patient Safety curriculum.

▪ Maintaining compliance with the Lilly Corporate Integrity Agreement.

7. A Clinical Research Physician, GPS Medical is expected to meet the criteria as outlined in the global path job criteria for the appropriate R path levels.

▪ For each level on every global path, there is a consistent set of job criteria which includes functional and technical expertise, decision making, influence, and problem solving.

**Minimum Qualification Requirements:**

▪ Medical Doctor or Doctor of Osteopathy. Must be board eligible or certified in appropriate specialty/subspecialty or have completed the comparable level of post-medical school clinical training relevant to the country of hiring.

▪ US trained physicians must have achieved board eligibility or certification. Foreign medical graduates (in US based jobs) who are not US board eligible or certified may be hired directly for employment in the US at the discretion of the Chief Medical Officer.

▪ Non-US trained physicians must have completed education and training at a medical school that meets the minimum requirements substantially equivalent to the requirements of medical schools accredited by the Liaison Committee on Medical Education (LCME). For the recognized list of foreign medical schools and the disapproved list, see[PLA: Physicians Licensing Information and Medical Education](<http://www.in.gov/pla/2799.htm>) | MBC

▪ Minimum 3+ years’ experience in the pharmaceutical industry or clinical care setting.

**Other Information/Additional Preferences:**

▪ Prior experience in clinical trials preferred; academic and/or industry.

▪ Clinical development or pharmacovigilance experience preferred

▪ Knowledge of drug development process

▪ Fluent in English with highly effective written and verbal communication skills

▪ Strong clinical/diagnostic skills

▪ Excellent interpersonal, organizational and negotiation skills

▪ Ability to work on multiple projects and function effectively in a fast-paced matrixed environment

▪ Ability to prioritize tasks and shift priorities rapidly to meet tight deadlines

▪ Ability to influence others (both cross-functionally and within the function) in order to create a positive working environment

▪ Excellent teamwork skills

▪ Willing to engage in domestic and international travel to the degree appropriate to support the business of the team

▪ Knowledge of global pharmacovigilance guidelines, guidance, and regulations (EMA, FDA, etc.) relevant to the activities and responsibilities described above Strategic thinking

▪ Demonstrated success in implementing projects and/or innovating

▪ Receptive, engaging, and impactful contributor

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ([https://careers.lilly.com/us/en/workplace-accommodation](<https://careers.lilly.com/us/en/workplace-accommodation>)) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$201,000 - $360,800

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

\#WeAreLilly

Director, Medical - Clinical Research Scientist

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

The Cardiometabolic Research (CMR) Program Clinical Research Scientist (CRS) participates in the following for compounds of responsibility for the therapeutic area, including an evolving portfolio of compounds targeting women’s health: the development, conduct and reporting of global clinical trials for new compounds, the implementation of global clinical trials, the reporting of adverse events as mandated by corporate patient safety; the review process for protocols, study reports, publications and data dissemination for products, new and updated labels, grant submissions and contracts, contacts with regulatory and other governmental agencies; assessment of licensing opportunities, and the outreach activities aimed at the external clinical customer community. In addition, the Clinical Research Scientist works with research scientists to identify lead compounds and clinical candidates and plan pre-clinical studies. Core tasks will be delegated based on level of experience.

Other activities include internal training activities, peer-review of clinical protocols and reports, and ad hoc scientific consultation within Lilly. The CRS works with late stage development colleagues to plan for meeting patient needs through clinical studies, and outcomes and pharmacoeconomic research.

**Responsibilities:**

This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. The primary responsibilities of the CMR Program Phase CRS are generally related to early-phase compounds, including those targeting women’s health.

The core job responsibilities may include those listed below as deemed appropriate by line management, as well as other duties as assigned.

Clinical Planning

- Contribute to the development of the overall strategy and clinical plan for development of clinical compounds, focusing on studies required for product decision. Support preparation of high-level plan for phase Ill studies.
- Collaborate with local clinical research staff, consultants and clinical investigators in the design, conduct and reporting of global Phase lb and Ila/IIb clinical trials (e.g., sample size, patient commitment, timelines, grants, and governance review interactions).
- Collaborate with other quantitative scientists (e.g., PK/PD, statistics, molecular epidemiology, ADME, modeling and simulations) to integrate study development and conduct with disease-progression and drug­ disease response models.
- Work closely with discovery research scientists in the development of basic research strategies, clinical candidate compound selection, and pre-clinical development.
- Collaborate with non-clinical pharmacologists to translate observations from animal experiments to human clinical studies (biomarker development) in the area therapeutic area of responsibility.
- Collaborate with drug disposition scientist to conduct pharmacokinetic and drug metabolism studies of drug candidates in humans.
- Assist pharmacokineticists and statisticians by providing clinical support to the development of pharmacostatistical models of drug exposure and response (PK/PD modeling and trial stimulation) to optimize dosing regimens and selection of the target patient population.

Clinical Research/Trial Execution and Support

- Design and oversee implementation of Phase lb and Ila/IIb clinical studies.
- Design and write clinical trial protocols.
- Design and oversee implementation methods for development and biomarker qualification studies.
- Collaborate with local clinical research staff, statisticians, health outcomes research scientists and selected consultants and/or investigators in the development of protocols, and data collection requirements.
- Participate in investigator identification and selection, in conjunction with clinical team.
- Interact with consultants and clinical investigators to plan, initiate, and conduct worldwide clinical trials (Phase I and II).
- Review and approve risk profiles, and local informed consent documents as required, to ensure appropriate communication of risk to study subjects.
- Ensure that operational team has documented the completion of administrative requirements for study initiation and conduct (i.e., ethical review board, informed consent, regulatory approval/notification) consistent with Good Clinical Practices (GCPs) and local laws and requirements.
- Assist in planning process and participate in study start-up meetings and other activities to provide the appropriate training and information to investigators and site personnel.
- Serve as resource to CDAs I clinical research monitors, investigators and ethical review boards to address any questions or clarify issues arising during the conduct of study.
- Understand and actively address the scientific information needs of all investigators and personnel.
- Monitor patient safety during the conduct of studies and conduct the appropriate tracking and follow-up of adverse events, in alignment with corporate patient safety policies and procedures.

Scientific Data Dissemination/Exchange

- Knowledge of and compliance with local laws and regulations, and global policies and procedures, compliance guidelines with respect to data dissemination and interactions with external health care professionals/customers.
- Understand and actively address the unsolicited scientific information needs of external health care professionals according to guidelines above.
- Participate in reporting of clinical trial data in Clinical Trial Registry activities.
- Consider, review or develop pharmacoepidemiologic (quality of life, cost/effectiveness) and health economic aspects.
- Support the planning of symposia, advisory board meetings, and other meetings with health care professionals.
- Participate in data analysis, development of scientific data dissemination and preparation of final reports.
- Support development of slide sets and publications (abstracts, posters, manuscripts).
- Support the creation and review of any scientific information with respect to customer questions or media request in accordance with global compliance policies and procedures.
- Provide congress support (e.g., availability to answer questions at exhibits, provide oral and poster presentations, staff medical booth, meet thought leaders, and participate in customer events).

Regulatory Support Activities

- Support/ assist in the preparation of regulatory reports, including the medical sections of the IND and Investigator Brochure, preparation of FDA advisory committee regulatory hearings and label discussions, and communications and resolution of regulatory issues, including regulatory response.
- Develop and review labeling modifications in collaboration with regulatory and safety groups.
- Participate in risk management planning along with GPS colleagues.
- Provide medical expertise to regulatory scientists.

Business/ customer support

- Understand the scientific/medical needs of all CMR Program Phase customers (payers, patients, health care providers
- Provide advice and consultation to global business unit with regard to potential markets for development compounds and in-licensed projects or compounds.
- Support business development in collaboration with the regulatory and corporate affairs group.
- Establish and maintain appropriate collaborations and relationships with external experts, thought leaders, and the general medical community on a national and possibly international basis.
- Participate in PhRMA or other local or national trade associations.
- Develop and maintain appropriate collaborations and relationships with relevant professional societies.
- Participate in patent development.
- Take a leadership role in defining the Patient Journey and corresponding Moments of Truth based on his/her medical knowledge. Become a patient advocate, as well as a medical expert.

Scientific & Technical Expertise and Continued Development

- Critically read and evaluate the relevant medical literature; know the status and data in medical field of interest; and keep updated with medical and other scientific developments relevant to the therapeutic area.
- Provide consultation to health outcomes staff, marketing professionals, and management regarding the potential medical need served by responsible therapeutic area drug candidates.
- Knowledge of current trends and projections for clinical practice and access in the therapeutic area(s) relevant to the development projects.
- Explore and take advantage of opportunities for extramural scientific experiences.
- Attend scientific symposia.
- Understand and keep updated with the pre-clinical, clinical pharmacology and clinical data relevant to the molecule.
- Maintain awareness of current clinical practices through experience or contacts.

**General Responsibilities**

- Actively set and meet individual professional development goals and contribute to the development of others by being an active source of coaching and feedback to co-workers.
- Actively participate in recruitment, diversity, and retention efforts.
- Participate in committees, initiatives and task forces as requested by local/corporate management.
- Model leadership behaviors and lead matrixed cross-functional teams.
- Be an ambassador of both patients and for the Lilly Brand.

**Basic Qualifications/Requirements:**

- PhD in a relevant field (i.e Endocrinology, Reproduction, Internal medicine, Development Biology, Immunology, Cell Biology, Physiology, Pharmacology, Neuroscience)
- 5+ years clinical development experience.

**Additional Information :**

- Clinical research or pharmaceutical medicine experience preferred.
- Knowledge of drug development process preferred.
- Fluent in English; both written and verbal communications.
- Interpersonal, organizational and negotiation skills.
- Ability to influence others (both cross-functionally and within the function) in order to create a positive working environment.
- Excellent teamwork skills.
- Willing to engage in domestic and international travel to the degree appropriate to support the business of the team.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ([https://careers.lilly.com/us/en/workplace-accommodation](<https://careers.lilly.com/us/en/workplace-accommodation>)) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$177,000 - $338,800

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

\#WeAreLilly

ADMA Biologics

Manager, Regulatory Affairs

Job Description

ADMA Biologics is a biopharmaceutical company relentlessly committed to creating superior products for immunodeficient patients at risk for infection. It is our devotion to this underserved population that fuels us and our hands-on approach to production and development that sets us apart. If you are looking for a dynamic, innovative, growing company in the biopharmaceutical industry that is committed to excellence and integrity, then consider ADMA Biologics. We currently have an exciting opportunity available for a **Manager, Regulatory Affairs in Boca Raton, Florida!**

Job Title: Manager, Regulatory Affairs

Job Description:

**Position Summary**

**This is an onsite, in-person position located in Boca Raton, Florida.**

The Manager, Regulatory Affairs, supervises and participates in planning, preparing and evaluating regulatory documents for submission to governmental regulatory agencies like U.S. Food and Drug Administration. Serves as a liaison with regulatory agencies and contractors, as well as an informative regulatory resource for cross-functional teams. Ensures corporate policies and procedures comply with regulatory requirements.

**Essential Functions (ES) and Responsibilities**

- Provides accurate and timely regulatory guidance to all company functions while maintaining frequent contact with Associate Director of Regulatory Affairs.
- Responsible for preparation, review, presentation, and evaluation of all regulatory submissions. Assess accuracy and completeness of submission documents throughout product lifecycle, specifically pre-application submissions (e.g., meeting requests), new application submissions (e.g., Investigational New Drug applications \[IND\], Biological License Applications \[BLA\], Orphan Drug applications \[OD\]), maintenance submissions (e.g., end-of-phase reports, annual reports, changes to IND or BLA Common technical Document \[CTD\] dossier, safety reports, product license renewals, establishment license renewals, meeting requests) and post-marketing submissions (e.g., annual reports, periodic safety reports, annual reports of Post-marketing requirements or commitments), and other related documents or submissions.
- Determines regulatory strategy that aligns with business strategy, defines submission requirements and coordinates the collection of required data, information, and documentation from pertinent departments, facilities, and affiliates, and from contractors/vendors as needed. Liaises with partner companies as appropriate.
- Plans regulatory milestones, sets timelines and assures timely, accurate and complete submissions to regulatory agencies. Provides signatory approval for reports and amendments or supplements to INDs or BLAs. Advises senior regulatory management of challenges to achieving timely, accurate or complete submissions.
- Oversees Regulatory Operations by developing or maintaining project timelines/milestones/submission tracking systems, and document archive systems. Practices regulatory process improvement by reviewing, writing and revising policies, standard operating procedures (SOP) and work instructions (WI) that ensure efficient and compliant regulatory processes.
- Works closely with Quality Assurance to conduct regulatory risk assessments of quality system documents and practices. Utilizes problem solving skills to recommend risk mitigation strategies, and to develop alternative courses of action or contingency plans.

**Education & Experience Requirements**

**Education Requirements:** Bachelor’s degree in Pharmaceutical, Biological or Chemical Science or related field. Advanced degree desirable.

**Experience Requirements:**

- Minimum of 7 years of practical pharmaceutical regulatory expertise across phases of drug development.
- Minimum of 5 years’ experience with Master’s degree.

**Preferred Experience**

- Effective written and verbal communication, collaboration, problem-solving, and negotiation skills.
- General knowledge of Good Manufacturing Practices, Good Clinical Practices, Good Documentation Practices, and Good Laboratory Practices.
- Excellent program management skills.
- Proficient in common office software applications.
- Must be able to represent ADMA Biologics with accuracy and sensitivity to regulatory issues.
- Detailed knowledge of laws and regulations, (specifically, US Federal Food, Drug and Cosmetic Act; Code of Federal Regulations; FDA guidelines), practices and international harmonization standards.
- Expert knowledge of Regulatory Affairs department SOPs.
- Must be able to balance multiple projects.
- Step-in to fill-in/take over ongoing projects with minimal notice.
- Multiple deadlines on conflicting projects with constant interruptions.

**Compliance Requirements (ES)**

The minimum compliance expectation for this role entails strict adherence to FDA regulations and company policies governing sales and marketing activities. This includes completion of required compliance training and adherence to data privacy regulations. Additionally, the role requires proactive participation in compliance reviews, prompt reporting of any potential issues, and ongoing education to stay updated on relevant FDA regulations.

Job Description Footer:

**In addition to competitive compensation, we offer a comprehensive benefits package including**:

- 401K plan with employer match and immediate vesting
- Medical, Vision, Life and Dental Insurance
- Pet Insurance
- Company paid STD and LTD
- Company Paid Holidays
- 3 Weeks’ Paid Time Off (within the first year)
- Tuition Assistance (after the first year)
- Easily accessible to Tri-Rail. Free shuttle to the Boca Tri-Rail station

ADMA Biologics uses E-Verify to confirm the employment eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit [www.dhs.gov/E-Verify](<https://www.dhs.gov/E-Verify>).

ADMA Biologics is an Equal Opportunity Employer.

Florida

AbbVie

Associate Director, Regulatory Affairs, Europe Regulatory Policy and Intelligence (all genders)

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](<http://www.abbvie.com/>). Follow @abbvie on [LinkedIn,](<https://www.linkedin.com/company/abbvie/>) [Facebook](<https://www.facebook.com/AbbVieGlobal/>), [Instagram](<https://www.instagram.com/abbvie/>), [X](<https://twitter.com/abbvie>) and [YouTube.](<https://www.youtube.com/user/AbbVie>)

Job Description

Welcome to AbbVie! As part of an international company with ca. 57,000 employees worldwide and around 3,500 employees in Germany, you will have the opportunity of addressing some of tomorrows unmet medical needs in close collaboration with your colleagues. Are you passionate about improving global health care? Do you want to contribute to improving patients' quality of life through your expertise? In a challenging work environment that offers opportunities of developing and increasing your own skills? Youve come to the right place!

Together, we break through – as **Associate Director, Regulatory Affairs, Europe Regulatory Policy and Intelligence (all genders)**

The Associate Director, Europe Regulatory Policy & Intelligence (RPI), will be a strong subject matter expert in regulatory policy and procedure, laws and regulations with a comprehensive understanding of how regulatory policy is shaped and developed within Europe, and the business context for R&D. Also, in this role you will lead assigned regulatory policy topics in a collaborative cross-functional environment and will work closely with counterparts from US/C and JPAC. The role will address policy and intelligence assimilation, analysis of changes in the regulatory environment, development of policy positions and advocacy strategies to advance policy goals through internal and external collaboration to ensure alignment with AbbVie portfolio priorities.

**Make your mark:**

- Independently manages and leads regional topics in the regulatory policy and intelligence function. Defines scientific and regulatory policy initiatives within assigned areas. A high level of proactivity and business acumen is required.
- Serves as policy subject expert based on in depth knowledge of key regulatory issues and scientific basis. Analyzes proposed policies with clear emphasis on communicating impact of trends. Leads formation of corporate position to share with trade associations, ensuring cross functional alignment.
- Prepares and presents complex written and oral reports to Senior Management and external audiences on scientific and regulatory topics. Exceptional communication skills are needed to translate complex data into high-value insights.
- Effectively uses negotiation skills to resolve policy issues when unable to agree internally. Anticipates and communicates consequences of path chosen.
- Serves as liaison to trade associations for management on scientific and regulatory issues.
- Supports supervisor and Senior Management in discussions of complex policy topics at trade associations.
- Contributes to regulatory product development strategy by responding to information requests and providing an analysis of the regulatory environment.
- Conducts external outreach with regulators, peers, and trades. Creates and responds to opportunities to enhance AbbVie’s relationship by participating in policy-related meetings. Utilizes local network of pharma companies to obtain policy-related information.

Qualifications

**This is how you make a difference:**

- Bachelor\`s degree in Pharmacy, Chemistry, Biology, Pharmacology, Law or a related health or life- science discipline.
- 10 + years in pharmaceutical industry or with a health authority, including hands-on regulatory policy experience and an established regulatory network across Europe
- Proven ability to translate policy trends into corporate positions and to influence and negotiate with internal and external stakeholders in a complex matrix environment
- Excellent communication skills, with the ability to make complex scientific and regulatory topics clear for senior management and external audiences
- Excellent written and oral English communication skills

**What we offer you:**

- with a diverse work environment where you can have a real impact
- with an open corporate culture
- with an attractive salary
- with an intensive onboarding process with a mentor at your side
- with flexible work models for a healthy work-life balance
- with a corporate health management that offers comprehensive health and exercise programs
- with company social benefits
- with a wide range of career opportunities in an international organization
- with top-tier, attractive development opportunities
- with a strong international network

At multiple times, we have been globally recognized as a "Great Place to Work" and we are proud to provide our employees with the flexibility to maintain a healthy work-life balance. We take our impact on the environment and our communities seriously and therefore focus on giving something back on a regular basis. We are committed to equality, equity, diversity and inclusion (EED&I) – a commitment that is fundamental to us. This includes appreciating different perspectives, creating an inclusive culture and treating all employees with dignity and respect.

At AbbVie, your individual contributions count – help us move mountains together. Be a part of our success, grow with us and accomplish more than you could have imagined. Sounds like the perfect career opportunity for you? We look forward to receiving your application! All you need is a complete CV – we will discuss everything else with you in person.

Any questions? Feel free to email us at TalentAcquisition.de@abbvie.com – We are looking forward to hearing from you!

Additional Information

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](<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](<https://www.abbvie.com/join-us/reasonable-accommodations.html>)

Clinical Research Associate

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.co.uk](<http://www.abbvie.co.uk/>). Follow @abbvie on [LinkedIn,](<https://www.linkedin.com/company/abbvie/>) [Facebook](<https://www.facebook.com/AbbVieGlobal/>), [Instagram](<https://www.instagram.com/abbvie/>), [X](<https://twitter.com/abbvie>) and [YouTube.](<https://www.youtube.com/user/AbbVie>)

Job Description

- Field-based CRA position
- Reporting to Clinical Operations Manager
- Excellent development opportunities, reward and benefits package

**Job Overview**

Advance AbbVie's pipeline by striving for excellence in clinical research, turning science into medicine for our patients and leveraging advanced capabilities to drive industry leading performance. Partners with study teams, AbbVie internal R&D stakeholders, investigators, and site staff for meaningful and effective engagements positioning AbbVie as the partner of choice in clinical trials.

Focus on site clinical research that ensures appropriate conduct of the trial while driving improvement in data integrity, compliance, overall study performance and customer experience.

**Responsibilities**

- Considered as the Primary Sponsor Point of contact for the investigative site. Experience in providing contextual information on the clinical trials, connecting stakeholders to the investigative sites and strengthening AbbVie's positioning
- Aligns, trains and motivates the site staff and principal investigator on the goals of the clinical trial program, protocol, and patient treatment principles for the trial ensuring a trusted partnership. Able to support, guide, and mentor junior personnel on Site Management activities
- Conducts site evaluation, site training, routine on-site and off-site monitoring, and site closure monitoring activities with compliance to the protocol and monitoring plans, in accordance with applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and quality standards, ensuring safety and protection of study subjects
- Understanding of site engagement and ability to customize site engagement strategy for assigned study/ies and critically apply new strategies as needed. Gather local/site insights and utilize site engagement tools to report/track progress and measure impact of that strategy
- Able to connect the study protocol, scientific principles and clinical trial requirements to the day-to-day clinical trial execution activities. Understanding to generate and ensure effective recruitment and retention techniques/plans based on the patient disease journey
  Develop solid knowledge of therapeutic area, asset and clinical landscape / patient journey to enable successful patient recruitment and overall protocol compliance."
- May participate/lead in global/local task forces and initiatives. Responsible for activities as assigned by manager
- Responsible for continuous risk-assessment proactively, and in collaboration with Central Monitoring team, monitor activities conducted by clinical sites to detect early overall study performance or patient safety issues. Superior ability to think critically to resolve site risk signals while having robust understanding of site processes to drive study execution. Ensures preventative and corrective action plans are put into place, as needed, to mitigate risk and promote compliance
- Independently Identifies, evaluates and recommends new/potential investigators/sites on an on going basis demonstrating expert understanding and decision making. Potential sites may be identified through networking or internal AbbVie requests to assist in the placement of planned clinical studies with qualified investigators.
- Ensures quality of data submitted from study sites and assures timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel. Ensures audit and regulatory inspection readiness at assigned clinical site at all times. Manages investigator payments as per executed contract obligations, as applicable.

Qualifications

- Appropriate tertiary qualification in health related disciplines (e.g., Medical, Scientific, Pharmacy, Nursing) preferred or experience
- Independent clinical research monitoring experience of investigational drug or device trials in any therapeutic area. Familiar with risk‐based monitoring approach, onsite and offsite monitoring
- Knowledge of appropriate therapeutic area indications with the ability to understand and apply scientific concepts as they relate to the conduct of clinical trials
- Knowledge on existing and emerging local regulatory and legal requirements, ICH/GCP Guidelines and applicable policies
- Demonstrate advanced communication skills and superior cross-functional collaboration skills among internal and external stakeholders
- Demonstrate strong planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines
- Ability to leverage technology, tools and resources to provide customer centric support based on the health of the site
- Excellent interpersonal skills with strong written, verbal, active listening and presentation skills, with ability to establish and leverage site relationships and trusted partnerships through engagement, motivation, and training
- Ability to independently use functional expertise, leverage critical thinking skills and apply good judgement to address clinical site issues
- Acts with integrity in accordance with AbbVie code of business conduct and leadership values. Self-motivated individual focused on delivering timely and quality outcomes in a fast-paced environment.

Additional Information

AbbVie's UK offices in Maidenhead prioritize accessibility and employee well-being, creating a welcoming environment for everyone. The office includes a large car park for easy access, as well as step-free entry, accessible restrooms, and elevators to accommodate individuals with mobility challenges. The workspace features assistive technologies and adaptable workstations, fostering an inclusive culture. Additionally, there is a dedicated quiet zone for those who prefer to work without distraction. This area maximizes natural light and is strategically positioned for easy access with minimal noise disturbances. If you need specific information or have questions about accessibility arrangements, please let us know during the process.

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](<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](<https://www.abbvie.com/join-us/reasonable-accommodations.html>)

Senior Manager, Regulatory Affairs US & Canada Strategy Lead – Aesthetics Device (Hybrid)

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](<http://www.abbvie.com/>). Follow @abbvie on [LinkedIn,](<https://www.linkedin.com/company/abbvie/>) [Facebook](<https://www.facebook.com/AbbVieGlobal/>), [Instagram](<https://www.instagram.com/abbvie/>), [X](<https://twitter.com/abbvie>) and [YouTube.](<https://www.youtube.com/user/AbbVie>)

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](<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](<https://www.abbvie.com/join-us/reasonable-accommodations.html>)