Manager, Regulatory Dossier Management

Manager – Regulatory Dossier Management

Are you an experienced regulatory professional with a passion for developing people and driving regulatory excellence? Join us as Manager, Regulatory Dossier Management and lead a highly skilled team at the heart of Lundbeck’s global regulatory activities – from early development through marketing authorization and life-cycle management.

Your new role

You will be leading a team of highly skilled colleagues and act as coach to support them in their daily job. You will in collaboration with other team leads assign/coordinate resources and ensure prioritization of Regulatory Dossier Management activities. Part of the job is to ensure the development of competencies and skills of the employees through the Individual Development Plan. You could also be responsible for coordinating and leading the execution of the global regulatory strategies for some drug projects and perhaps Line of Business projects. It will give you the opportunity to develop and maintain strong collaboration and communication with all other key functional areas in Lundbeck.

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 lead one of our three teams within a department of approximately 20 highly skilled and dedicated colleagues. We value collaboration, knowledge sharing and continuous learning, and we take pride in supporting one another to achieve our shared goals. As a leader, you will have the opportunity to foster an inclusive team environment where people are encouraged to grow, contribute and make an impact.

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

What you bring to the team

We are looking for a collaborative and people-focused leader who combines strong regulatory expertise with the ability to inspire and develop others.

We expect you to have:

• A university degree in a relevant life science or medical discipline, along with at least 10 years of experience in Regulatory Affairs within the pharmaceutical industry.
• A solid understanding of pharmaceutical regulations and guidelines, with broad awareness of the global regulatory environment.
• The ability to prioritize, coordinate and drive multiple activities while building strong relationships across functions.
• Previous people management experience is an advantage, but not a requirement. We also welcome candidates with strong leadership potential and a genuine passion for coaching and developing others.

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.