Director, Regulatory CMC - Cell Therapy

Role: The Director of Regulatory CMC for Cell Therapy oversees management of multiple development and lifecycle projects, representing GRS-CMC in cross-functional teams, governance, and regulatory engagements. Responsibilities include developing and communicating global regulatory strategies, preparing and reviewing CMC submissions, ensuring compliance, and supporting external regulatory interactions and health authority meetings. The role also involves leading and mentoring direct reports, monitoring regulatory guidelines, and contributing to policy development. Requirements: BA/BS degree, at least 10 years of pharmaceutical experience with 8+ years in regulatory CMC, with knowledge of advanced therapies, biologics, and cell therapies during development and post-approval. Key competencies include expertise in CMC regulatory requirements, pharmaceutical development processes, cross-functional leadership, and global regulatory strategy development. HighValue: focus on cell therapy, advanced therapies, biologics, drug development stages from clinical to post-market, global regulatory compliance, and leadership in regulatory submissions and strategy. The position may require up to 5% travel and is based on-site or hybrid.