Director, Regulatory CMC - Cell Therapy

Role: Director, Regulatory CMC for Cell Therapy, overseeing global management of development and lifecycle projects, representing GRS-CMC in cross-functional and regulatory engagements. Responsibilities: develop and communicate regulatory strategies, oversee CMC submission preparation, review technical content, ensure compliance, and support team growth. Qualifications: minimum BA/BS with 10+ years pharma experience, including 8+ years in regulatory CMC; knowledge of advanced therapies, biologics, and cell therapy processes; strong leadership, cross-functional collaboration, and regulatory strategy skills. HighValue: cell therapy, biologics, advanced therapies, development and post-approval stages, global regulatory interactions, CMC dossier management, and compliance. WorkSetup: hybrid, with some travel (~5%).