Experteer Overview
Compruebe que cumple con los requisitos de habilidades para este puesto, así como con la experiencia asociada, y luego envíe su CV a continuación.
In this role you drive regulatory strategy and submissions for pioneering cell therapies from AZ’s Global Regulatory Strategy Team. You collaborate with senior experts to plan, coordinate, and execute regulatory activities across regions, shaping pathways and accelerating development. You influence health authority engagements and leverage risk/solution analyses to keep programs on track. You will empower cross-functional teams with regulatory guidance in a dynamic, patient-centric development landscape. This position offers impact through steering high-impact regulatory decisions at scale.
Compensaciones / Beneficios
• Define stage-appropriate regulatory strategy aligned with integral requirements for cell-based gene therapies
• Monitor evolving regulatory guidelines to inform development plans
• Lead and contribute to planning, preparation, and submission of regulatory dossiers (e.g., IND, CTA,



GMO, BLA, IVDR)
• Advise on opportunities to accelerate development by evaluating risks and proposing solutions
• Participate in Health Authority meetings to gather feedback and shape submission strategies
• Develop, execute, and maintain submission delivery/content plans with status updates to stakeholders
• Support operational and compliance activities for assigned projects
• Coach and mentor Regulatory Affairs xqbhyrx team members and contribute to governance and process improvements
Responsabilidades
• Bachelor’s degree in a scientific discipline, Regulatory Sciences, Pharmacy, or related field
• 5+ years regulatory experience in biopharma, health authority, or related area
• Thorough knowledge of drug development
• Strong project management skills
• Leadership experience leading multi-disciplinary project teams
Requisitos principales
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📌 Associate Regulatory Affairs Director (Barcelona)
🏢 AstraZeneca
📍 Barcelona