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Associate Director Regulatory Affairs
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- The Associate Director, Regulatory Affairs will establish and grow internal CMC regulatory activities, providing strategic management and content plans to support Vyriads gene therapy product development, registration, and post-approval strategies.
- The position will be responsible for crafting and assuring development and execution of regulatory strategies for biological drug products and combination products globally, providing direction on the interpretation and application of global CMC regulations and guidance related to gene therapy.
- Provides regulatory guidance and strategy for gene therapy programs, including assessing and identifying regulatory risks
- Manages activities with emphasis on regulatory strategy preparation, review and submission of documents for FDA (e.g. pre-INDs, INDs, IMPDs, BLAs, MAAs, BPDRs, annual reports, DSUR, amendments, supplements) and other regulatory authorities
- Functions as liaison responsible for communicating with FDA and other regulatory authorities
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