Director, Regulatory Affairs, CMC

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.

Pay

TBD

Schedule

N/A