Manager CMC Regulatory Affairs

Regeneron Pharmaceuticals; Rensselaer (IN); Vor Ort; USD 108.000 - 176.000; Vollzeit

Zusammenfassung

Regeneron Pharmaceuticals is seeking a Manager, CMC Regulatory Affairs - Biologics to lead regulatory strategy for biologics across development, submissions, and post‑market activities. This on‑site role involves coordinating with Global Regulatory Affairs and CMC teams to ensure compliance and timely submissions.

You will engage with FDA and other authorities, translate complex regulatory requirements into actionable plans, and drive process improvements across the organization.

Qualifikationen

• Bachelor’s degree with 6+ years in pharmaceutical/biotech or Health Authority settings.
• 2–4 years of CMC Regulatory Affairs experience with worldwide regulations.
• Experience delivering CMC sections of MAAs, CTAs/INDs, and post‑approval submissions.
• Biologics experience and FDA interactions are preferred.

Aufgaben

• 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 regulations and guidelines.
• Support regulatory authority interactions, including meetings and information requests.
• Develop Working Instructions, SOPs, and Reviewer’s Guides to improve consistency.

Kenntnisse

Regulatory strategy

CMC regulatory affairs

Cross‑functional collaboration

Communication

Negotiation

Problem solving

Ausbildung

Bachelor's degree

Advanced degree

Jobbeschreibung

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 or Warren, New Jersey

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 Reviewer’s 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:

• Bachelor’s 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.

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 on‑site. Please speak with your recruiter and hiring manager for more information about on‑site 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.

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 on‑site. Please speak with your recruiter and hiring manager for more information about on‑site 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