Manager CMC Regulatory Affairs
$108k - $176kRegeneron Pharmaceuticals, Inc.
Manager overseeing CMC regulatory strategy and compliance for biologic products across development, submissions, and post-market programs. The role involves leading regulatory initiatives, collaborating across global teams, and ensuring adherence to applicable regulations in an on-site position.
Responsibilities
- Lead CMC regulatory strategies for assigned biologic products across all development phases
- Support CMC activities from early phase through submission and post-market monitoring
- Evaluate product changes and deviations for regulatory impact and filing requirements
- Review regulatory filings for compliance with applicable regulations and industry guidelines
- Facilitate 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 16 days ago
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