Are you ready to leverage your integral regulatory expertise to drive cross‐functional success and make a real impact across diverse international markets? Do you thrive in multicultural settings and have a natural ability to collaborate seamlessly across borders? If you're ready for a high‐visibility role guiding regulatory strategies across multiple regions, this could be your next career challenge at ALK.
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.
Your primary tasks will be to:




Collaborate with Global Regulatory Leads to translate regulatory strategies into actionable project plans and timelines.
Identify critical regulatory milestones, dependencies, risks, and opportunities that may impact development programs and product registrations.
Facilitate cross‐functional planning meetings and ensure alignment of regulatory deliverables and timelines.
Lead planning and tracking of global regulatory submissions, including new marketing applications, variations, renewals, line extensions, and post‐approval changes.
Ensure submission schedules are realistic, resource‐aligned, and communicated effectively to stakeholders.
Monitor submission readiness and proactively address risks that could impact timelines.
Maintain visibility of regulatory activities and develop contingency plans to address potential delays or regulatory challenges within IM.
Ensure alignment between

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