Senior Director, Regulatory Affairs (Oncology)

Senior Director, Regulatory Affairs for Oncology leads the development and implementation of global regulatory strategies aligned with asset and corporate goals. Responsible for timely preparation of organized, scientifically valid submissions and for providing regulatory expertise to cross-functional teams. Responsibilities include interacting with regulatory authorities, conducting regulatory intelligence, assessing risk for various regulatory scenarios (including expedited pathways), leading multi-disciplinary teams in planning regulatory strategies for early and late-stage programs, coordinating with external vendors for CTA submissions in Europe, Asia, and other regions, reviewing trial-related documentation for regulatory compliance, leading the preparation and submission of regulatory documents (INDs, NDAs, BLAs, DSURs, amendments), developing internal SOPs, and supervising a team. Travel approximately 20%. Education/Experience requirements include a Bachelor's with 15+ years, or a Master’s with 13+ years, or a PhD with 12+ years, or an equivalent combination, with strong leadership, communication, and regulatory expertise in global markets.