Are you ready to leverage your integral regulatory expertise to drive cross‑functional success and make a real impact across diverse international markets? Position As Senior Regulatory Affairs (RA) Manager , you will be the key RA in contact with the Head of International Markets and global stakeholders. Your mission: together with Global Regulatory Leads to develop and drive integrated regulatory strategies and plans that support the timely development, registration, lifecycle management, and commercialization of ALK’s pharmaceutical products in the International Markets region.
You will work in close partnership with Clinical Development, CMC, Supply Chain, Quality, Commercial, and regional teams—ensuring all regulatory activities, milestones, and submissions aligned with our global business objectives.
Collaborate with Global Regulatory Leads to translate regulatory strategies into actionable project plans and timelines.
Lead planning and tracking of global regulatory submissions, including new marketing applications, variations, renewals, line extensions,



and post‑approval changes.
Ensure alignment between regulatory plans and commercial launch objectives.
Prepare regulatory planning metrics, dashboards, and status reports for leadership and governance forums.
Guide regulatory communication between external commercial partners and ALK Global Regulatory Affairs.
This is a truly international role, reporting directly to the Head of Global RA, Safety & Pharmacovigilance, and working closely with the Head of International Markets. The position is not remote but the job location is flexible. A bachelor’s degree in Life Sciences, Pharmacy, Regulatory Affairs, or a related scientific discipline (master’s degree preferred).
~5+ years of experience in Regulatory Affairs, Regulatory Operations, Regulatory Project Management, or Regulatory Planning within the pharmaceutical industry.
~ Extensive knowledge of global pharmaceutical regulatory processes and requirements, inclu

📌 Senior Regulatory Affairs Manager (Madrid)
🏢 ALK
📍 Madrid