Director, Global Regulatory Affairs CMC

Role: Lead GRA CMC Regulatory specialist within Takeda's R&D, focusing on developing and executing regulatory strategies for biopharmaceutical products in clinical and post-approval stages. Responsibilities: independently lead regulatory CMC submissions (INDs, BLAs, MAAs), contribute to project teams, represent Takeda in health authority meetings, and oversee compliance and risk management across product lifecycle. Requirements: BS/BA in Science; 10+ years industry experience with at least 8 years in pharmaceutical regulatory CMC or device areas, including major submission leadership. Preferred: advanced degree (M.S., Ph.D.), extensive global regulatory knowledge, and leadership experience in drug development, analytical development, manufacturing, or quality assurance. HighValue: expertise in global CMC regulations, experience with biologics or complex modalities, involvement in development and commercialization phases, and proven stakeholder collaboration. WorkSetup: hybrid in Boston, MA; traveling as needed.