Job Title: Regulatory Affairs Manager

Introduction To Role

This role is based in Barcelona, with an on-site commitment of three days a week. Fluency in English is required.

Are you ready to steer complex, high-impact registrations across international markets and bring transformative medicines to patients with rare diseases? Based in Barcelona, you will drive regulatory strategy and execution for unique, technologically advanced products that address areas of significant unmet need.

In this role, you will connect science, policy, and business to achieve timely approvals and robust lifecycle management. You will partner closely with integral and local stakeholders across development, commercial, and medical functions to expand the reach of our portfolio and maintain compliance at every step. Can you see yourself shaping strategy one day and orchestrating a flawless submission the next?

Accountabilities

Submission Planning and Delivery: Build, align,



and deliver regulatory submission plans for assigned products and programs across International markets to meet business objectives and accelerate patient access.
Submission Coordination Support: Coordinate timelines, documentation, and cross-functional inputs to ensure complete, accurate, and on-time submissions in line with regional requirements.
Health Authority Engagement: Prepare for and support strategic interactions with regulatory authorities, enabling clear, consistent positions and positive outcomes for key milestones.
Regulatory Compliance Assurance: Maintain rigorous adherence to internal standards, local regulations, and global policies, ensuring inspection readiness and reliable documentation.
Regulatory Intelligence: Monitor evolving regulations and trends across relevant jurisdictions and development stages, and translate insights into actionable guidance for teams.
Enterprise Collaboration: Provide regulatory input to Commercial, Medical, and other partners to shape evidence generation, claims strateg

📌 Regulatory Affairs Manager (Barcelona)
🏢 Alexion Pharmaceuticals,Inc.
📍 Barcelona