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Responsibilities:
- Lead all operational and lifecycle management aspects of Regulatory CMC submissions (e.g., INDs, IMPDs, BLAs, MAAs, variations, amendments) supporting cell therapy development programs.
- Develop and execute global regulatory CMC strategies that align with program objectives, regulatory requirements, and overall business strategy.
- Serve as the Regulatory CMC lead on cross-functional program teams, providing strategic regulatory guidance for cell therapy development and lifecycle management.
Qualifications:
- Bachelor’s degree in scientific discipline (e.g., Chemistry, Biochemistry, Biology, Chemical Engineering, or related field).
- 8+ years of Regulatory CMC and/or drug development experience, including direct experience supporting FDA-regulated cell therapy products.
- Familiarity with GMP principles and documentation practices.
BrainChild Bio
BrainChild Bio is a kids-first company focused on developing innovative cell therapies for patients with devastating diseases. We are a small, mission-driven company with a rapidly growing, dynamic environment.