Director, Regulatory CMC
Third Rock Ventures•Lexington, MA
403d
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About The Position
The Director, Regulatory CMC will provide regulatory CMC leadership for program teams developing biologic and cell and gene therapy products. This position is responsible for driving global CMC RA strategy and execution, including the generation of quality dossiers to support Health Authority meetings, INDs/CTAs/IMPDs, and marketing applications in collaboration with stakeholders. This position will partner with SMEs across the organization to author and review key regulatory documents, represent the organization at health authority meetings, and help shape the regulatory organization.
