Sr. Director, Regulatory CMC

Role: Senior Director of Regulatory CMC responsible for global lifecycle management of approved and late-stage gene therapy products, focusing on post-approval activities, change management, and regulatory compliance. Responsibilities: develop and execute strategies for post-approval submissions (supplements, variations, annual reports), oversee change management for manufacturing and analytical processes, lead interactions with health authorities (FDA, EMA), ensure inspection readiness, and mentor the Regulatory CMC team. Collaborate with Technical Operations, Quality, Supply Chain, and Program teams to align regulatory and operational plans. Requirements: Bachelor's or Master's in life sciences; minimum 15 years in biopharma with extensive post-approval CMC experience in cell and gene therapies; proven track record leading regulatory submissions and inspections; in-depth knowledge of GMP, CMC regulations, and global frameworks. Preferred: PhD, strong leadership skills, strategic thinking, and experience supporting commercial manufacturing of complex biologics or gene therapies. High-Value: extensive post-approval CMC lifecycle expertise, gene therapy focus, regulatory leadership in a global context, and cross-functional collaboration. Work Setup: hybrid in Somerville, MA; travel details not specified.