Associate Director, Global Regulatory Affairs CMC

Role: Lead Global Regulatory CMC strategist within Takeda's R&D organization, focusing on developing and executing regulatory strategies for investigational, registration, and post-approval drug or device products. Responsibilities: independently manage CMC regulatory submissions across development stages, represent Takeda in health authority meetings, evaluate change proposals for global impact, ensure regulatory compliance, and provide tactical guidance to cross-functional teams. Qualifications: BS/BA in a scientific discipline; 10+ years industry experience with at least 5 years in Regulatory CMC or Devices, including leading major variations or initial submissions; deep understanding of global CMC regulations and guidelines; proven ability to communicate with health authorities and internal teams. High-Value: Role supports biopharmaceutical products in development and commercialization, with a focus on pharmaceuticals and devices, across all regulatory stages. Work Setup: Hybrid in Boston, MA, with no travel specified.