Senior Director, Global Regulatory Lead – Oncology

Role: Senior Director, Global Regulatory Lead – Oncology, responsible for shaping and executing regulatory strategies for high-priority oncology programs across global development stages. Responsibilities include leading global regulatory teams, providing strategic insights, managing complex submissions (e.g., NDA/BLA/MAA), and ensuring timely, compliant approvals with a focus on innovative biologics, ADCs, and small molecules. The role involves collaborating with cross-functional teams, engaging with regulatory agencies (FDA, EU, ROW), and supporting global market access. Requirements: BSc/BA in a scientific discipline; advanced degree (PharmD/PhD/MD preferred); 12+ years in pharma with at least 10 years in regulatory affairs; proven experience in late-stage development and regulatory submissions; strong knowledge of global regulatory requirements, including FDA and EMA. Preferred skills include strategic thinking, leadership, and cross-functional collaboration. HighValue: Oncology, biologics, ADCs, small molecules, late-stage development, regulatory submission leadership, global coordination, interaction with agencies, and market access. WorkSetup: hybrid Boston; reporting to senior management with global stakeholder engagement.