Associate Director, Global Regulatory Affairs - GI & Inflammation

Role: Associate Director of Regulatory Affairs leading global regulatory strategies for complex projects within Takeda's R&D. Objectives include ensuring regulatory success, compliance, and timely approvals, especially US FDA submissions. Responsibilities involve leading Global Regulatory Teams (GRTs), defining and executing global regulatory strategies, managing FDA interactions, overseeing submissions, and aligning strategies with regional authorities. The role also includes risk management, cross-functional collaboration, and monitoring regulatory trends. Qualifications: Bachelor's degree in a scientific discipline; advanced degree (PharmD, PhD, MD) preferred; 6+ years in pharma, with 4+ years in regulatory; strong knowledge of drug development, FDA, EU, and other international regulations; experience managing regulatory submissions and cross-functional teams. High-Value: Focus on complex or multiple projects, global regulatory strategy, US FDA submission leadership, experience with drug development stages, and cross-cultural team coordination. Work setup: Hybrid in Boston, MA, with a competitive salary range and comprehensive benefits.