Director, Global Regulatory Labeling Strategy

Role: Director of Global Regulatory Labeling Strategy at Takeda, focusing on developing and executing labeling content and strategies across multiple products and stages of drug development, including high-complexity assets. Responsibilities: lead cross-functional labeling teams, coordinate with senior management and global oversight committees, author and review labeling documents (TLP, CCDS, USPI, EU SmPC), manage local labeling exceptions, and oversee labeling negotiations with Health Authorities. Collaborate with global teams across regulatory, clinical, safety, medical affairs, and commercial functions, while managing external vendors. Ensure compliance with US and EU labeling regulations, analyze competitor and industry labeling trends, and support regulatory inspections. Lead and develop a team, foster cross-functional relationships, and drive process improvements. Qualifications: BSc (preferably MSc, PhD, or PharmD), with 10+ years industry experience, including at least 8 years in labeling or related regulatory functions. Expertise in US and EU labeling requirements, strong strategic, analytical, and negotiation skills, and proven leadership in cross-functional global teams. High-value specifics include experience with regulated product labeling, regulatory submissions, and multi-regional compliance. Location: Remote (Massachusetts), with an emphasis on global collaboration.