Regulatory Senior Scientist - Regulatory Dossier Management

Regulatory Senior Scientist – Regulatory Dossier Management

We are looking for a Regulatory colleague to join us and to take part in the journey of restoring brain health. You will be part of an organisation where we stand at the centre of it all, from the earliest stages of drug development all the way through life cycle management.

Your new role

You will be responsible for coordinating and leading the execution of the global regulatory strategies with a high degree of complexity, working mainly on development project as well as coordinating regulatory activities. You will represent Regulatory Dossier Management in a regulatory team comprised of your global and local regulatory colleagues to deliver on the business strategy. Your responsibilities will mainly be to prepare/contribute to Clinical Trial Applications globally, with the possibility of initial Marketing Applications, line extension and coordination of global maintenance activities. Furthermore, you will represent regulatory in cross functional teams and provide regulatory expert knowledge, maintain strong collaboration and communication with other key functional areas.

Your future team

The position is placed in the Department of Regulatory Dossier Management. We are accountable for proactively execute on the global regulatory strategies of Lundbeck’s portfolio which means planning and coordinating regulatory tasks for the very first studies in humans and follow them through marketing authorization and life-cycle management opportunities. We are a large team of 19 people with a good vibe who support each other and are keen to learn more and develop.

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

What you bring to the team

We expect you to have:

• university credentials in a relevant life science or medical discipline,
• preferably with a few years’ experience working in regulatory affairs,
• a good understanding of pharmaceutical guidelines/legislation and awareness of the global regulatory environment.

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 Nina Heric, Manager in Regulatory Dossier Management, +45 30 83 27 40. Applications must be received by 15th December 2025.

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.