Director, Global Regulatory Lead - Oncology

Role: Director, Global Regulatory Lead Oncology at Takeda, responsible for developing and executing global regulatory strategies for high-impact oncology programs, including ADCs, biologics, and small molecules in clinical development. Main objectives include leading regulatory submissions, ensuring timely FDA approvals (notably NDA/BLA/MAA), and managing regional and global regulatory teams. Responsibilities encompass overseeing all regulatory activities for assigned projects, serving as primary FDA contact, and collaborating globally to align regulatory strategies. The role involves leading interactions with health authorities, monitoring regulatory trends, and supporting product development and licensing due diligence. Qualifications: Bachelor’s degree in a scientific discipline (advanced degree preferred), 8+ years in pharmaceutical regulatory affairs with strong FDA knowledge, and experience managing major regulatory filings. Skills in strategic planning, cross-functional leadership, and effective communication are essential. High-value specifics: oncology focus, biologics and small molecules, clinical stage (development support), US FDA-driven, including complex submissions. The role reports to senior management, works in a hybrid Boston setting, and entails some travel. Emphasis on leadership, strategic regulatory expertise, and global coordination for innovative oncology therapies.