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. BrainChild Bio is a kids-first company focused on developing innovative cell therapies for patients with devastating diseases, and this role plays a critical part in ensuring that every product delivered meets the highest standards of quality, safety, and reliability.
The Director, 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 individual will be expected to provide guidance to the program teams and will be responsible for preparation of CMC and Quality related agency correspondences and regulatory applications ensuring all applicable regulatory requirements are considered and appropriately incorporated into the lifecycle of each program.
The ideal candidate is detail-oriented, highly organized, and motivated by the opportunity to make a direct impact on patients’ lives. 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.
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.
- 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).
- Evaluate the regulatory impact of CMC changes through formal change control processes and define and execute appropriate filing strategies.
- 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.
- 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.
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.
- Strong attention to detail, organizational skills, and ability to manage multiple priorities.
- 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.
