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As Regulatory Affairs Manager, you will lead end-to-end regulatory planning and delivery for assigned programs. You will contribute to submission strategy and manage risks and opportunities across regions, guiding cross-functional teams toward timely approvals. You’ll handle simple to increasingly complex regulatory applications and oversee documentation and procedures in collaboration with health authorities. You work closely with global and regional teams to align regulatory plans with product lifecycle goals and business objectives. This role offers a meaningful impact by shaping regulatory strategy in a dynamic, global biopharma environment.
Compensaciones / Ventajas
• Develop submission strategies and plans for multiple markets/regions
• Lead planning, preparation, and delivery of regulatory submissions across product lifecycle




• Review regulatory documents and study-related materials for compliance
• Identify regulatory risks and provide mitigations with cross-functional teams
• Coordinate project plans (e.g., Planit inputs) and manage resource changes
• Support TMF and document management; coordinate with CROs and alliance partners
• Provide coaching and knowledge sharing within the RAM group
• Contribute to process improvement and compliance activities
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Responsabilidades
• Bachelor's degree in Regulatory Sciences, Pharmacy, or related field
• 3+ years of regulatory experience in biopharma or health authorities
• General knowledge of drug development
• Strong project management and leadership experience
• Ability to lead multi-disciplinary project teams
Requisitos principales
• inclusive culture
• lifelong learning and development
• diversity and collaboration

📌 Regulatory Affairs Manager (Barcelona)
🏢 AstraZeneca
📍 Barcelona