BrainChild Bio
Director, Regulatory Affairs, CMC
United States · Director
Sponsorship not specifiedDetected 6 days ago
GMPFDA RegulatoryCommunicationOrganizational SkillsRegulatory Affairs
About the role
- Manager, Regulatory Affairs, CMC is accountable for executing on the global CMC regulatory strategies across multiple products.
- This role contributes to the planning, preparation, and submission of regulatory CMC documentation.
- The ideal candidate is detail-oriented, highly organized, and motivated by the opportunity to make a direct impact on patients' lives.
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.
- Collaborate cross‑functionally to ensure CMC deliverables meet regulatory requirements, quality standards, and program timelines.
- Drive continuous improvement and best‑practice sharing for Regulatory CMC processes in a rapidly growing, dynamic environment.
- BrainChild Bio is seeking a Director, Regulatory Affairs, CMC, to support implementation of the global regulatory CMC strategy across our clinical-stage cell therapy programs.
Requirements
- 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.
- Effective communication skills and ability to work cross-functionally.
- Ability to thrive in a fast-paced, mission-driven, small company environment and adapt to shifting priorities.
- Occasional travel required.
- Strong attention to detail, organizational skills, and ability to manage multiple priorities.
Benefits
- This role offers the opportunity to work cross-functionally with development teams, and with relevant external parties including contract manufacturing organizations, expert consultants, and global health authorities.
- Author, review, and coordinate Module 3 (M3) content, ensuring consistency, quality, and alignment across global regulatory submissions (e.g., US, EU, and other international health authorities).
- Proactively identify CMC regulatory risks, anticipate Health Authority questions, and develop of mitigation and contingency strategies to support successful outcomes.
- Lead or contribute to interactions with health authorities by preparing briefing packages, technical justifications, responses to information requests, and regulatory meeting support.
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