Director, Regulatory Affairs, CMC
New
United StatesFull-TimeDirector
Salary not disclosed
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Job Details
- Experience
- 8+ years
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.
- 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.
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.
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