EU Regulatory Affairs Director

Are you driven by the challenge of acting as the primary Regulatory Affairs contact between commercial and local regulatory teams? Do you have a strategic mindset and developed stakeholder management skills?

The position
As the EU Regulatory Affairs Director, you will act as a formal point of Regulatory Affairs (RA) contact for the Head of Commercial Operations Europe and local EU RA teams. You will develop, maintain and drive global regulatory overview and integrated regulatory plans that support the timely development, registration, lifecycle management, and commercialization of pharmaceutical products across EU.

Your primary tasks will be:

• Guide and oversee EU RA strategies through support to regulatory scenario planning and assessment of alternative submission strategies.
• Coordinate and sequence regulatory work across the EU for highest-value impact and effective use of resources.
• Facilitate cross-functional meetings and ensure alignment of regulatory deliverables and timelines.
• Consolidate and communicate EU regulatory intelligence.
• Represent RA in the Marketed Products Committee (MPC): Provide regulatory input to cases, secure decisions, and oversee execution.
• Develop and own a framework for prioritizing RA resources across maintenance, LCM, and pipeline; Align recommendations with commercial and R&D priorities.
• Maintain a consolidated global RA resource/FTE/cost/timeline view, produce forecasts and dashboards, and recommend allocations and trade-offs.
• Prepare strategic RA communications and inputs for MPC, PPPCom, and executive leadership on regulatory matters.
• Act as regulatory representative in business development activities.
• Coordinate and provide input to new business opportunities and budgets and advise on regulatory timelines and specifications.

This is a truly global role with stakeholders across Europe. In this role, you will report directly to the Head of Global RA, Safety & Pharmacovigilance whilst working closely with the Head of Commercial Operations Europe. The position can be based in one of our European office locations and you should expect some travel (primarily within Europe) as part of the role.

Your profile
We expect that you have:

• An advanced degree in life sciences, pharmacy, or a related field (PharmD, PhD, MD, or MSc).
• 10+ years senior EU regulatory affairs experience in pharmaceuticals/biologics.
• Leadership experience is preferred. 

Your personal attributes and competences:

• Developed personal networking and relationship building skills.
• Think and act strategically.
• Understand details while keeping a "big picture" view of projects and strategies.
• Proven ability to lead in a matrix environment, influence without authority, and negotiate effectively with regulators and senior internal stakeholders.

Become a part of ALK
ALK is a global pharmaceutical company specializing in allergy immunotherapy. We are driven by a high level of professionalism, integrity, an open-minded approach and contributing to an inspiring and fun working environment together with our colleagues. We provide an attractive working environment for individuals looking for both personal and professional development. You will be part of an engaged and informal team who values skill and knowledge creation. 

Do you want to learn more about our company, we encourage you to visit us at www.alk.net.

Apply
Apply by attaching your CV and a short letter of motivation, no later than 9 August 2026.

We commit to an inclusive recruitment process and equal opportunity for all our job applicants. Hence, we prefer that you do not add images to your application documents. We evaluate applications and call for interviews on an ongoing basis, so don't wait to apply! We reserve the right to take down the advert when we have found the right candidate.

We are looking forward to hearing from you!