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Responsibilities:
- Lead operational and lifecycle management aspects of Regulatory CMC submissions such as INDs, IMPDs, BLAs, MAAs, and amendments.
- Develop and execute global regulatory CMC strategies that align with program objectives.
- Author, review, and coordinate Module 3 content for global regulatory submissions.
Qualifications:
- Bachelor's degree in a scientific discipline (e.g., Chemistry, Biochemistry, Biology).
- 8+ years of Regulatory CMC or drug development experience with cell therapy products.
- Strong attention to detail and ability to manage multiple priorities.
Additional Info:
- Occasional travel required.
- Use of AI tools in hiring process.
Brainchild Bio
BrainChild Bio is a kids-first company focused on developing innovative cell therapies for patients with devastating diseases. It operates as a small, mission-driven company in a fast-paced environment.