Director, Regulatory Affairs - CMC

Role: Lead global regulatory CMC strategy for biologics, overseeing product development, registration, and post-approval lifecycle management. Responsibilities: develop and execute robust CMC regulatory strategies, prepare high-quality dossiers for submissions (e.g., BLA/NDA, INDs), manage agency interactions, interpret regulatory guidance, and ensure compliance with GMP and global standards. Collaborate across Regulatory Affairs, Technical Operations, and Quality teams to facilitate approvals and maintain regulatory intelligence. Requirements: Bachelor's in a scientific discipline, 8-10+ years in regulatory CMC within biotech/pharma, with extensive biologics experience; knowledge of gene/cell therapies a plus. Skills include translating scientific data into regulatory documents, global regulatory expertise, excellent communication, collaboration, and project management. High-Value: biologics, gene/cell therapies, global submissions, post-approval lifecycle, GMP environment, ICH guidelines, up to 10% travel. Work setup: not specified, but involves cross-functional collaboration in a fast-paced, matrixed environment.