Experteer Overview
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In this role you shape the integral regulatory direction for first-in-class cell and gene therapies, driving timely approvals and competitive labels. You will lead cross-functional strategy from discovery to commercialization, influencing health authority interactions and lifecycle planning. You’ll build and mentor a regulatory strategy team, advancing policy and governance to sustain a competitive edge. This position offers high-impact work at scale, shaping patient access to breakthrough medicines.
Compensaciones / Beneficios
• Own end-to-end global regulatory strategy for complex CGT programs through BLA submission, approval, and lifecycle management
• Act as Regulatory Affairs representative on Global Product Teams, guiding development plans and risk management
• Lead health authority engagement and strategy for submissions, designations, and labeling negotiations
• Maintain external insights to influence regulatory policy and maintain competitive advantage
• Lead one or more Global Regulatory Strategy Teams, coach and develop regulatory talent
• Provide executive risk assessments and governance on emerging data and program options
• Ensure timely milestone delivery, dossier construction, and labeling strategy




• Promote innovative regulatory tools and modern ways of working to improve quality and speed
• Collaborate cross-functionally with marketing, regional teams, and stakeholders to align regulatory perspectives
Responsabilidades
• Advanced degree in science-related field and 10+ years in regulatory strategy
• Proven success in cell and/or gene therapy regulatory strategy
• Deep knowledge of global regulatory science and portfolio integration
• Extensive experience with drug/biologic development for complex, first-in-class programs
• Experience in oncology, autoimmune, rare diseases, or neurology therapeutic areas
• Broad pharmaceutical xqbhyrx background with cross-functional regulatory experience
• Leadership of regulatory and cross-functional teams with senior stakeholder influence
• Strategic, enterprise-level thinking; strong risk assessment abilities
• Significant experience in Health Authority interactions in major markets
• Excellent communication, organizational skills, and adaptability in fast-paced settings
• Experience with due diligence and business alliances; coaching and talent development
Requisitos principales
• in-office collaboration three days per week
• flexible work arrangements
• diverse and inclusive environment

📌 Executive Director, Regulatory Affairs Strategy - Cell Therapy (Barcelona)
🏢 AstraZeneca
📍 Barcelona