Director, Global Regulatory Affairs, Neuroscience

Role: Director of Global Regulatory Affairs in Neuroscience, leading regulatory strategies for Takeda's neuroscience portfolio. Responsibilities: develop and lead global regulatory strategies, manage cross-functional Global Regulatory Teams, ensure compliance, oversee US FDA submissions (including complex NDA/BLA filings), and represent Takeda in interactions with regulatory agencies like FDA. Provides strategic guidance, monitors global regulatory trends, and collaborates across teams to optimize product development and approval pathways. Requirements: BSc degree (preferred BA), 10+ years in pharma, with at least 6 years regulatory experience; strong knowledge of drug development, FDA, EMA, and other global regulations; experience with regulatory submissions and agency interactions; excellent communication, negotiation, and strategic skills. Preferred: experience in neuroscience therapeutic areas, managing complex submissions, and leading international regulatory teams. HighValue: neuroscience, regulatory strategy, FDA submissions (NDA/BLA), cross-functional leadership, global regulatory compliance, experience with complex submissions and agency negotiations. WorkSetup: hybrid Boston; role involves leadership in global regulatory strategy and agency interactions.