Director, Regulatory CMC

Beam Therapeutics

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.

Responsibilities

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

Requirements

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

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Vacancy posted 20 days ago

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