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? In this role, you will connect science, policy, and business to achieve timely approvals and robust lifecycle management. You will partner closely with global 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?
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.
Regulatory Compliance Assurance: Maintain rigorous adherence to internal standards, local regulations, and integral policies,



ensuring inspection readiness and reliable documentation.
Monitor evolving regulations and trends across relevant jurisdictions and development stages, and translate insights into actionable guidance for teams.
Provide regulatory input to Commercial, Medical, and other partners to shape evidence generation, claims strategy, and launch readiness for the International region.
Contribute to internal decision forums and continuously improve regulatory processes, SOPs, and audit/inspection support frameworks.
Opportunity Identification: Identify and prioritize areas where AI tools can streamline workflows, reduce cycle times, and improve submission quality.
Design and validate prompt-based and agentic AI solutions that enhance documentation, planning, and data analysis while meeting regulatory quality and compliance standards.
Bachelor's degree in a relevant field.
~ Strong knowledge of drug development and regulatory pol

📌 Compliance Manager/Senior Manager (España)
🏢 Alexion Pharmaceuticals,Inc.
📍 España