Associate Director, CMC Regulatory

Role: CMC Regulatory Affairs Lead for next-generation cell therapy (CAR T-cell) development, supporting all product lifecycle stages and regulatory submissions. Responsibilities: provide phase-appropriate guidance on CMC regulatory requirements, manage risk assessments, develop content for INDs, amendments, IMPDs, and support BLA/MAA submissions; coordinate regulatory projects and timelines; maintain knowledge of global regulations; collaborate on regulatory documents (e.g., Investigator Brochures, Annual Reports). Requirements: MSc or PhD in a scientific discipline; at least 8 years of experience in CMC regulatory affairs within biotech/pharma, with proven expertise in lifecycle management from IND to market; experience with cell therapies preferred; strong understanding of FDA, EMA, ICH guidelines; excellent communication skills; ability to multi-task in a fast-paced environment; familiarity with AI tools for regulatory writing. Preferred: global regulatory experience, 2+ years management experience. HighValue: cell therapy, regenerative medicine, CMC lifecycle management, IND to BLA/MAA, regulatory risk mitigation, cross-functional collaboration. WorkSetup: not specified.