Regulatory Specialist

Regulatory Specialist – Regulatory Dossier Management

Are you an experienced Regulatory professional who enjoys driving complex global submissions and collaborating across functions? Join Regulatory Dossier Management and play a key role in bringing innovative treatments to people living with brain disorders - from early development through life-cycle management.

Your new role

You will be responsible for coordinating and leading the execution of global regulatory strategies for complex development projects. Working closely with global and local regulatory colleagues, you will represent Regulatory Dossier Management within cross-functional regulatory teams and help deliver Lundbeck's business objectives.

In this role, you will prepare and contribute to Clinical Trial Applications worldwide and coordinate the submission of initial Marketing Authorization Applications. You will also provide regulatory expertise to cross-functional project teams, build strong partnerships across the organization, and play an important role in ensuring high-quality regulatory deliverables throughout the product development lifecycle.

Your future team

The position is part of the Regulatory Dossier Management department. We play a central role in executing Lundbeck's global regulatory strategies, planning and coordinating regulatory activities from the very first studies in humans through marketing authorization and life-cycle management.

You will join a department of approximately 20 highly skilled and dedicated colleagues, organized into three collaborative teams. We value knowledge sharing, continuous learning and open communication, and we take pride in supporting one another to achieve our shared goals. It is a team with a positive atmosphere, where people are encouraged to contribute, develop their expertise and make a meaningful impact.

The position is based in Lundbeck Headquarters, in Copenhagen (DK).  

What you bring to the team

We are looking for a collaborative Regulatory professional who enjoys navigating complex regulatory challenges and building strong partnerships across functions.

We expect you to have:

• A university degree in a relevant life science or medical discipline and at least six years of experience in Regulatory Affairs within the pharmaceutical industry.


• Hands-on experience planning and coordinating regulatory submissions and supporting global clinical trial applications.


• A solid understanding of pharmaceutical legislation, regulatory guidelines and the global regulatory environment.


• Strong communication and stakeholder management skills, enabling you to collaborate effectively across functions and contribute to complex global projects.

Our promise to you

Lundbeck offers an inspiring workplace and innovative culture, where our curiosity, accountability and adaptability enable us to transform lives. We want to go faster and further on addressing the big unmet needs of people living with brain disorders. We offer rewarding careers with a mix of exciting tasks and development opportunities that are balanced with initiatives focused on your well-being.

We need every brain in the game, and at Lundbeck, we are committed to building a workforce that is as diverse as the people we serve. Read more about our commitment at www.lundbeck.com/global/about-us/our-commitment/diversity-and-inclusion.

Apply now

Can you see yourself in this role? We want to hear from you. Does this sound like your dream job, but you’re not sure if you meet all the requirements? We still want to hear from you!

Upload your CV and include a few lines about your motivation for applying. We ask you not to include a photo or personal information that does not relate to your professional experience.

If you have questions or want to hear more, please feel free to contact Malin Axelsson, Head of Global Regulatory Operations. Applications must be received by 7th August 2026.

Learn more about us at www.lundbeck.com, LinkedIn or Instagram (@h_lundbeck).

#EveryBrainInTheGame

This job ad is intended for individuals seeking a career opportunity with Lundbeck. We engage with recruitment and search firms where needed on the basis of a written agreement, and we do not accept unsolicited requests of any kind. If you work as a recruitment consultant, you are kindly instructed to refrain from contacting Lundbeck or the hiring manager directly with suggested candidates. If you violate this policy, you do so at your own risk and for your own account, and Lundbeck will not assume any liability nor pay any associated fees resulting from such violation.