About this opportunity
Regeneron Pharmaceuticals Inc. lists this Manager, CMC Regulatory Affairs - Biologics opportunity in village of tarrytown, New York. Review the employer’s description below for duties, qualifications and application requirements.
Job description
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 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.
Requirements
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.
Equal Opportunity
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.
Salary
Salary Range (annually) $108,000.00 - $176,000.00
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
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Who can apply
Review the original listing for work authorization, qualifications and employer requirements.