Experteer Overview
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In this role you will set the global regulatory direction for first-in-class cell and gene therapies, turning science into timely medicines. You will lead strategy across discovery to commercialization, enabling fast, data-driven decisions and meaningful labels that support patient access. You will shape interactions with health authorities, define target product labeling, and accelerate submissions across indications and modalities. As a senior leader, you will develop regulatory talent, influence policy, and sustain a competitive edge for the portfolio. This is a high-impact opportunity to drive lifecycle value and integral access for transformative therapies.
Compensaciones / Beneficios
• Own end-to-end global regulatory strategy for a complex CGT product or franchise from development through approval and lifecycle management
• Represent Regulatory Affairs on Global Product Teams and provide strategic regulatory advice
• Lead strategies for health authority engagements, expedited designations, and labeling negotiations to secure timely approvals
• Maintain external regulatory insights and influence policy to sustain competitive advantage
• Lead Global Regulatory Strategy Teams; coach and develop regulatory talent; manage 3–7 team members
• Deliver objective assessments of emerging data,



update senior management on risks and strategic options
• Ensure delivery of regulatory milestones, including dossier preparation and labeling, and oversee lifecycle planning
• Drive innovation in regulatory tools and modern ways of working to improve quality and speed
• Coordinate with cross-functional and regional teams to deliver cell therapies to patients
• Contribute to due diligence, external policy, and industry advocacy initiatives
Responsabilidades
• Advanced degree in a science-related field and 10+ years of relevant experience
• Proven success in cell and/or gene therapy regulatory strategy
• Deep understanding of global regulatory science and integration with program strategy
• Extensive experience xqbhyrx in high-profile, complex, novel development programs
• Experience in oncology, autoimmune, rare diseases, or neurology therapeutic areas
• Broad pharma regulatory experience and cross-functional team leadership
• Strong strategic, enterprise-level thinking with risk assessment abilities
• Significant experience in Health Authority interactions in major markets
• Excellent communication, organizational skills, and ability to work in fast-paced environments
• Experience in mentoring and developing regulatory talent
• Experience with due diligence and business alliances
• Contribution to external policy or regulatory science initiatives
Requisitos principales
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📌 Executive Director, Regulatory Affairs Strategy - Cell Therapy (Barcelona)
🏢 AstraZeneca
📍 Barcelona