Director, Regulatory CMC

Role: Director, Regulatory CMC, leading global lifecycle and change management strategies for approved and late-stage gene therapy products. Responsibilities: oversee post-approval CMC activities including submission of supplements, variations, and reports; develop and implement change management strategies; support manufacturing, supply continuity, inspection readiness, and regulatory interactions with authorities (FDA, EMA); author and review CMC documentation; ensure compliance with global regulatory standards; monitor emerging guidance and inspection trends; mentor junior team members; collaborate cross-functionally with Tech Ops, Quality, Supply Chain, and Program teams. Qualifications: Bachelor’s or Master’s in life sciences; 10–12+ years in biopharmaceutical CMC regulatory affairs, particularly biologics or gene therapies; experience with post-approval submissions and global regulatory frameworks (FDA, EMA, ICH); strong communication, organizational, and cross-functional collaboration skills. High-Value: gene therapy, post-approval lifecycle management, global regulatory compliance, GMP, CMC change strategies, inspection readiness. WorkSetup: hybrid in Somerville, MA; no travel specified.