Associate Director, CMC Regulatory Affairs (Cell & Gene Therapies)
US - Cambridge Kendall SQ - MAonsitedirector$136K – $203K
Posted yesterday · via Workday
About this role
The Associate Director, Regulatory Affairs, CMC - Cell & Gene Therapies (CGT) supports the development and successful performance of the CMC regulatory strategy for the innovative pipeline of Cell & Gene Therapies. This position is hybrid, and may be based in Santa Monica, CA, Gaithersburg, MD or Boston, MA and reports to the Senior Director, CMC-CGT Regulatory Affairs. Essential Functions and Responsibilities Interpret global regulations and guidance to identify risks and provide input for guidance to cross functional product teams. Partner with cross-functional stakeholders to deliver regulatory dossiers (e.g. CMC component(s) of IND / IMPD / BLA/ Master Files, amendments, annual reports) and health authority interaction briefing documents.…
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This role is based in US - Cambridge Kendall SQ - MA. We weight your proximity and willingness to relocate.
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