Manager CMC Regulatory Affairs, Cell & Gene Therapy

Regeneron Pharmaceuticals, Inc.; Kentucky; On-site; USD 108,000 - 176,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. in the United States seeks a Manager, CMC Regulatory Affairs - Biologics to lead regulatory strategies across development, submissions, and post-market programs for biologics, including cell and gene therapy products and synthetic oligonucleotides.

This on-site role collaborates with Global Regulatory Affairs and CMC teams to ensure compliance and timely filings. The role requires 2–4 years of CMC Regulatory Affairs experience, strong communication, and the

Qualifications

• 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.
• Experience delivering CMC sections of marketing authorizations, CTA/INDs, and post-approval submissions.
• Experience with cell and gene therapy products and synthetic oligonucleotides 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.

Responsibilities

• Lead CMC regulatory strategies for assigned products including cell and gene therapy products and synthetic oligonucleotides.
• 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.

Skills

Regulatory strategy

Cross-functional collaboration

Regulatory submissions

Regulatory compliance

Education

Bachelor’s degree in pharmaceutical/biotech field

Advanced degree (MS/PhD) in related field

Job description

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: Locations: Warren, New Jersey; Tarrytown, New York and Rensselaer, New York Work model: Hybrid - 4 days a week on-site (5 days a week in Rensselaer)

Discover your role: Lead CMC regulatory strategies for assigned products including cell and gene therapy products and synthetic oligonucleotides 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 products including cell and gene therapy products and synthetic oligonucleotides strongly 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?

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.

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

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurology, infectious diseases and rare diseases.

Regeneron is also proud of award winning culture of innovation, being recognized as a Great Place to Work in 2021, Fast Company's Best Workplace for Innovators in 2020, and Forbes JUST companies in 2020, among others.