Experteer Overview
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In this role you will set the global regulatory direction for first-in-class cell therapies, translating science into timely approvals and impactful labels. You will lead strategy across discovery to commercialization, shaping engagement with health authorities and lifecycle management. As a senior leader, you’ll build capability, coach regulatory talent, and influence policy to sustain a competitive edge for the pipeline. You’ll work with cross-functional teams to accelerate submissions and bring therapies to patients with unmet needs. This position offers an opportunity to influence global strategy and drive meaningful patient impact.
Compensaciones / Incentivos
• Own end-to-end global regulatory strategy for a high-complexity cell therapy program through BLA submission and lifecycle management
• Represent Regulatory Affairs on Global Product Teams and guide development plans and risk management
• Lead health authority engagement, response strategies, and labeling negotiations to secure timely approvals
• Maintain external insight on regulatory science and policy to sustain competitive advantage
• Lead one or more Global Regulatory Strategy teams, coaching and developing senior regulatory talent
• Provide executive assessments of data and risks to inform senior leadership decisions
• Ensure delivery of regulatory milestones, create strategy documents and core labeling, oversee global dossier construction




• Drive innovative regulatory tools and new ways of working to improve quality and speed
• Collaborate with marketing, regional teams and cross-functional stakeholders to align regulatory views and policy interpretations
• Contribute to non-project initiatives at portfolio or enterprise level
Responsabilidades
• Advanced degree in a science-related field
• Extensive success in cell therapy regulatory strategy
• Deep understanding of global regulatory science and portfolio strategy
• Experience with drug/biologic development processes for complex, first-in-class programs
• Experience in oncology, autoimmune, rare diseases, or neurology therapeutic areas
• Broad pharmaceutical industry experience and regulatory affairs background
• Proven leadership of regulatory and xqbhyrx cross-functional teams in matrix environments
• Strategic, enterprise-level thinking with risk assessment abilities
• Significant experience in health authority interactions in major markets
• Excellent communication, organizational, and presentation skills
• Ability to manage multiple projects in a fast-paced, flexible manner
• Experience with due diligence and business alliances
• Experience in growing teams through coaching or mentoring
• Contribution to external policy, regulatory science, or industry advocacy initiatives
Requisitos principales
• office-based 3 days per week expected
• flexible working arrangements
• inclusive environment with accommodations
• career development and leadership opportunities

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