Director, Global Regulatory Labeling Strategy

Role: Director, Global Regulatory Labeling Strategy at Takeda, overseeing labeling content and strategy for multiple products across development stages. Responsibilities: lead cross-functional labeling teams, coordinate with senior management and global labeling oversight committee, author and revise labeling documents (TLP, CCDS, USPI, SmPC), manage local labeling exceptions, and negotiate with health authorities. Ensure compliance with US/EU regulations, analyze competitor and regulatory trends, and contribute to continuous process improvement. Manage vendor activities and support health authority inspections. Requirements: BSc (advanced degree preferred), 10+ years in pharma, including 8+ years in labeling or related regulatory roles. HighValue: focus on innovative therapies, global labeling strategy, cross-functional collaboration, and leadership in regulatory compliance. WorkSetup: remote Massachusetts-based position.