Are you ready to leverage your global 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 integral 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 regulatory plans and commercial launch objectives.
- Identify, assess, and communicate regulatory planning risks and mitigation strategies.
- 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 General RA, Safety & Pharmacovigilance, and working closely with the Head of International Markets. The position is not remote but the job location is flexible. You can be based in one of our European offices, with some international travel expected.

Your profile

We expect that you have:

- 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, including FDA, EMA, ICH, and other major health authorities.
- Demonstrated experience managing international regulatory programs and submissions.
- Experience from commercial interaction is an advantage as well as experience working within a general matrix organization and across multiple geographic regions.

Your personal attributes:

- Developed stakeholder management skills and the ability to influence without direct authority.
- Proactive, self‑motivated, and results driven.
- Driven by working in multicultural settings with an instinctive ability to connect and collaborate across global teams.
- Highly organized and detail‑oriented while being resilient in a fast‑paced, changing environment.
- Strong problem‑solving and decision‑making capabilities.
- Commitment to quality, compliance, and continuous improvement.
- Willingness to travel 20‑30 days per year.

Equal Opportunity

We commit to an inclusive recruitment process and equal opportunity for all our job applicants.

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📌 Senior Regulatory Affairs Manager - International Markets (España)
🏢 ALK
📍 España