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 global 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 integral 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 Requests, Letter

📌 Senior Director Compliance (Galicia)
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📍 Galicia