Director, Regulatory Site CMC

Role: Director of Regulatory Site CMC at Takeda, focusing on managing post-approval change control and regulatory compliance across multiple manufacturing sites for small molecules and biologics. Responsibilities include leading site-specific change management activities, applying ICH Q12 principles, driving process standardization and automation, and collaborating with external partners to align change control strategies. Qualifications: BS/BA in a scientific discipline, 10+ years in biopharma, with 8+ years in Regulatory CMC supporting global drug development and post-market activities, including experience with major variations and supporting IND/IMPD or NDA/BLA filings. Preferred skills include deep understanding of global health authority requirements beyond EU/US, scientific and regulatory strategy development, and leadership in cross-functional teams. High-Value: Involves global regulatory compliance, post-approval change management, with emphasis on science-based, scalable, and sustainable processes. Location: Boston, MA, with a hybrid work setup. The role offers a salary range of $177,000–$278,080, with potential incentives and benefits aligned with US standards.