Experteer Overview
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In this role you will lead the end-to-end regulatory strategy and submission execution for cell therapy programs, partnering with global experts to advance innovative therapies. You will navigate evolving guidelines, manage regulatory deliverables, and counsel cross-functional teams to accelerate development. Your work directly supports patient access through timely, compliant interactions with health authorities. This is a hands-on, cross-regional role that combines strategy, execution, and mentorship within a dynamic regulatory function.
Compensaciones / Beneficios
• Partner with the global regulatory team to define stage-appropriate regulatory strategy for cell-based gene therapies
• Monitor evolving regulatory guidelines globally to support scientifically rigorous development plans
• Lead and contribute to planning, preparation, review, and submission of regulatory submissions (IND, CTA, GMO, BLA, IVDR) across regions




• Advise on opportunities to accelerate development by assessing risks and proposing solutions to regulatory hurdles
• Participate in meetings with health authorities to gather feedback and inform submission strategies
• Develop, execute, and maintain submission delivery and content plans with status updates to stakeholders
• Support operational and compliance activities for assigned projects
• Provide coaching, mentoring and knowledge sharing within the Regulatory Affairs Management skill group
• Contribute to governance meetings and process improvements
Responsabilidades xqbhyrx
• Bachelor's degree in a scientific discipline, Regulatory Sciences, Pharmacy, or related field
• 5+ years of regulatory experience in biopharma, health authority, or equivalent
• Thorough knowledge of drug development
• Strong project management and leadership experience
• Experience leading cross-disciplinary project teams
• Preferred: Master’s, PharmD, or PhD; 7+ years experience; experience with complex regulatory deliverables and IVDR/GMO submissions
Requisitos principales
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📌 Associate Regulatory Affairs Director (España)
🏢 AstraZeneca
📍 España