Manager, CMC Regulatory Affairs - Biologics
Regeneron Pharmaceuticals, Inc.
Regeneron seeks a Manager of CMC Regulatory Affairs for biologics to lead regulatory strategy and compliance activities across product development, submissions, and post-market programs. The role involves collaborating with regulatory and CMC teams to ensure compliance with global standards and support regulatory authority interactions.
Responsibilities
- Lead CMC regulatory strategies for assigned biologic products across development phases
- Support CMC activities from early development through submission and post-market stages
- Assess regulatory impact of changes and deviations to determine filing requirements
- Review regulatory filings for compliance with applicable regulations and guidelines
- Support regulatory authority interactions, including meetings and information request responses
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 requirements and guidelines
- Experience delivering CMC sections of marketing authorizations, CTAs/INDs, and post-approval submissions
- Experience with biologic products preferred
- FDA or other regulatory authority engagement experience preferred
- Strong communication, negotiation, strategic thinking, and problem-solving capabilities
Vacancy posted 7 days ago
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