Senior Director role leading global regulatory strategy for cell therapy programs across oncology, immune-mediated and rare diseases. Reports to Executive Director, Cell Therapy Regulatory Affairs, and oversees end-to-end strategy from current development stage through licensure, managing complex multi-indication programs and a General Regulatory Strategy Team.

Responsibilities

- Own end-to-end global regulatory strategy for complex cell therapy programs from current stage through BLA submission
- Lead strategy for health authority meetings, information requests, and expedited pathway designations
- Direct planning and construction of global dossier and target product labeling strategy
- Represent Regulatory Affairs on Global Product Teams and shape development and commercialization alignment




- Lead and mentor Global Regulatory Strategy Team for specific indications and programs

Requirements

- Bachelor's degree in science-related field
- 7+ years regulatory affairs experience
- Demonstrated success in cell therapy regulatory strategy
- Deep understanding of global regulatory science and program integration
- Experience leading at least one global regulatory approval including labeling negotiations
- Proven leadership of regulatory and cross-functional teams
- Experience with health authority interactions in major markets

📌 Senior Director, Regulatory Affairs Strategy (España)
🏢 AstraZeneca
📍 España