Manager, CMC Regulatory Affairs - Biologics
Regeneron Pharmaceuticals
Summary
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.
Job description
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.
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.
Benefits
- Annual bonuses
- Incentive plans
- Equity awards
- Pension or retirement benefits
- 401(k) company match
- Health and wellness programs
- Fitness centers
- Insurance benefits
- Paid time off
- Family support benefits
Company overview
Regeneron Pharmaceuticals is a leading American biotechnology company founded in 1988 and headquartered in Tarrytown, New York. The company specializes in inventing, developing, and commercializing life-transforming medicines for people with serious diseases. Regeneron is renowned for its innovative antibody technologies and has developed several groundbreaking therapies, including EYLEA® for retinal diseases, DUPIXENT® for inflammatory conditions, and the COVID-19 antibody cocktail REGEN-COV®. The company operates with a strong focus on research and development across multiple therapeutic areas including ophthalmology, oncology, cardiovascular diseases, and rare genetic disorders. Regeneron's proprietary VelocImmune® technology platform enables the rapid generation of fully human monoclonal antibodies. With over 15,000 employees globally and annual revenues exceeding $14 billion, Regeneron has established itself as a major force in the biotechnology industry, consistently ranking among the top-performing pharmaceutical companies and maintaining a robust pipeline of investigational therapies.