Manager, CMC Regulatory Affairs - Biologics
About The Position
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 give to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.
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.
- 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.
Nice To Haves
- Experience supporting biologic products preferred.
- Experience engaging with FDA or other regulatory authorities preferred.
Responsibilities
- 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.
- Translate ambiguity into actionable steps and build alignment across teams.
Benefits
- 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
- family support benefits
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What This Job Offers
Job Type
Full-time
Career Level
Manager
