The Senior Director, Regulatory Affairs is responsible for leading regulatory strategy and execution for assigned development programs, with a primary focus on oncology and broader disease areas as needed. This role will serve as the Global Regulatory Lead for designated assets and will be accountable for end-to-end regulatory leadership from early development through registration and lifecycle management, including IND/CTA, Health Authority meetings, Scientific Advice, Marketing Authorization Applications, and post-approval commitments. About the Role The Senior Director will provide strategic regulatory leadership to cross-functional teams to ensure timely and successful delivery of general development milestones, aligned with organizational portfolio priorities and business objectives. Responsibilities Global Regulatory Leadership (GRL): Regional Lead * Serve as global regulatory lead for assigned region/assets, owning the global regulatory strategy with primary accountability for key regulatory pathways. * Define and drive regulatory strategy for development, registration,



labeling, and lifecycle management for oncology and select non-oncology programs. * Lead cross-functional governance and ensure alignment of regulatory strategy with Clinical, CMC (Chemistry, Manufacturing, and Controls), Nonclinical, Safety, Biometrics, Medical, and Commercial stakeholders. Health Authority Engagement & Strategy * Lead planning and execution of Health Authority interactions (Scientific Advice, pediatric/post-authorization strategy where applicable, MAA pre-submission activities). * Act as primary regulatory liaison for assigned programs with relevant Health Authorities and support interactions with other key agencies as needed. * Translate evolving regulatory expectations into clear program-level plans and decision points. Major Submissions & Regulatory Deliverables * Provide strategic oversight and hands-on leadership for: IND/CTA, MAA submissions, Responses to Information Re

📌 Senior Director Regulatory Affairs (Álava)
🏢 Discover International
📍 Álava