Sr. Director, Regulatory Strategy

Role: Senior Director of Regulatory Strategy leading regulatory affairs and health authority interactions for gene therapies at Genetix Biotherapeutics. Responsibilities: develop and execute global regulatory strategies, support FDA and EMA engagements, lead lifecycle management, and oversee regulatory submissions for products in clinical and post-approval stages; partner cross-functionally with Medical Affairs, Clinical, CMC, Quality, and Commercial teams; manage regulatory teams and external consultants. Requirements: advanced degree in life sciences, 10+ years industry experience, 6+ years in regulatory affairs, proven success in FDA interactions and major US submissions; experience with biologics, cell, and gene therapies; strong regulatory knowledge including ICH countries and EU processes. Preferred: direct gene therapy experience, BLA approval support, PIPs, and European regulatory expertise. High-Value: focus on gene therapies, lifecycle management, FDA and EMA engagement, regulatory leadership for global product development, and strategic planning for market access. Work setup: hybrid in Somerville, MA, with candidates within commuting distance.