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Director / Senior Regulatory Affairs CMC
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$200,000 - $270,000 a year
Full-time
- The Director/Sr Regulatory Affairs will lead the overall CMC Regulatory strategy for Adverum’s gene therapy program/s.
- This individual will be the key interface between the Regulatory and CMC functions, partner with Process Development, Manufacturing, Supply Chain, and Quality; and assist in ensuring regulatory compliance.
- Manage the Regulatory Affairs (CMC) Strategy for Regulatory Affairs
- Strengthen internal gene therapy CMC capability and serve as regulatory subject matter expert and influential leader within the R&D organization to contribute to drug development at Adverum for its development programs
- Build the scope and design of experiments as well as troubleshoot the generation of robust GMP processes and analytics for Adverum’s gene therapy products
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