Senior Director/Director, Regulatory Affairs CMC
Beam Therapeutics · Cambridge, MA
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Role summary
Beam Therapeutics seeks a Senior Director or Director of Regulatory Affairs focused on Chemistry, Manufacturing, and Controls (CMC). This role leads regulatory strategy and CMC documentation for global gene editing therapeutic programs, from early development through regulatory submissions.
What they're looking for
- Extensive experience in regulatory affairs, CMC strategy, and health authority submissions
- Deep knowledge of gene therapy, cell therapy, or advanced biologics manufacturing requirements
- Demonstrated expertise developing IND, CTA, BLA, and MAA regulatory dossiers
- Experience leading cross-functional teams and communicating regulatory strategy
- Strong understanding of evolving regulatory landscape for innovative genomic medicines
What you'll be doing
- Provide CMC regulatory leadership and strategic guidance across development programs
- Develop and communicate regulatory strategies, risks, and key issues to stakeholders
- Serve as regulatory CMC lead and department representative in matrix development teams
- Define CMC content requirements and quality documentation for regulatory submissions
- Support manufacturing, analytical, and supply chain strategies with regulatory guidance
Privacy & handoff
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