Manager, CMC Regulatory Affairs - Biologics
$108k - $176kRegeneron Pharmaceuticals, Inc.
Manager leading CMC regulatory strategy and compliance for biologic products across development, submissions, and post-market activities. Collaborates with global regulatory and CMC teams to ensure regulatory alignment and support FDA/authority interactions.
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
- Support regulatory authority interactions including meetings and information requests
Requirements
- Bachelor's degree with 6+ years or advanced degree with 3+ years in pharmaceutical, biotechnology, or regulatory 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
- Strong communication, negotiation, strategic thinking, and problem-solving abilities
- Ability to build cross-functional partnerships and manage competing priorities
Vacancy posted 11 days ago
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