Director, Global Regulatory Affairs CMC

Role: Senior Regulatory CMC lead within Takeda's Global Regulatory Affairs, responsible for developing and executing regulatory strategies for complex drug products. Key responsibilities include leading global registration submissions, representing the company in health authority meetings, providing strategic regulatory input throughout product lifecycle, and mentoring team members. Requirements: BS/BA in scientific discipline with 10+ years in biopharma, including 8+ years in regulatory CMC or device functions, with experience leading major submissions such as NDAs, BLAs, or MAAs. Preferred skills: deep understanding of global CMC regulations, analytical and problem-solving capabilities, excellent communication, and leadership qualities. High-value: Extensive experience in pharmaceutical/biotech regulatory strategy, global submissions, and cross-functional collaboration across R&D, manufacturing, and quality. Therapeutic areas or modalities are not specified, but the role involves complex product registration and post-approval regulatory activities. Work setup: hybrid Boston location with full-time hours.