Associate Director, Global Regulatory Lead, Oncology

Role: Associate Director, Global Regulatory Lead Oncology at Takeda, responsible for defining and executing global regulatory strategies for oncology programs, including complex biologics and small molecules in clinical development. Responsibilities: lead regulatory teams, manage US FDA submissions and interactions, serve as primary FDA contact, and coordinate cross-regional regulatory efforts to ensure compliance and successful approvals. Also involved in regulatory assessments for licensing opportunities and monitoring industry trends to adapt strategies accordingly. Requirements: Bachelor's degree (scientific preferred), 6+ years in pharmaceutical regulatory roles, with strong knowledge of drug development processes, global regulatory environments (FDA, EU, Canada), and experience with complex submissions. Skills in scientific interpretation, strategic planning, negotiation, and cross-functional collaboration are essential. Preferred: advanced scientific degree, experience in oncology (ADC, biologics, small molecules), and familiarity with global health authorities. Work setup: Hybrid in Boston, MA, with the potential for international collaboration. The role demands leadership in regulatory strategy, stakeholder communication, and ensuring global regulatory success for innovative oncology therapies.