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. Por favor, lea detenidamente la información de esta oferta de empleo para entender exactamente qué se espera de los posibles candidatos. This role will serve as the Integral 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 RoleThe Senior Director will provide strategic regulatory leadership to cross-functional teams to ensure timely and successful delivery of global development milestones, aligned with organizational portfolio priorities and business objectives.
ResponsibilitiesGlobal Regulatory Leadership (GRL): Regional LeadServe 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 & StrategyLead 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 Deliv

📌 Director of Regulatory Policy Projects (Valencia)
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