Global Regulatory Strategy Lead; Director or Senior Specialist

Global Regulatory Strategy Lead; Director or Senior Scientist

We are currently looking for a Global Regulatory Strategy Lead; Director or Senior Specialist to join the Global Regulatory Strategy Leads team (currently 10 leads) to work on development project(s) to provide new treatments to patients with CNS diseases. 

Your new role

In this role, you will take the regulatory strategic leadership responsibility for one or few development projects in different stages of development.

You will be working in matrix organization with variety of stakeholders. As a member of Global Project Team(s) you will be expected to provide strategic input and regulatory expertise, work on innovative regulatory strategies, define regulatory tactics including planning and leading Health Authorities interactions, provide input to clinical development plans, evaluate regulatory risks, and recommend mitigating actions. You will be chairing regulatory focus team to ensure thorough regulatory assessments and execution of regulatory strategies.

You will be expected to be proactive toward stakeholders and advance the projects by leading toward decisions, evaluation of scenarios and taking calculated risks. You will also be expected to proactively contribute to strengthening the capabilities and competences of the Global Regulatory Strategy function by proactively sharing knowledge, building culture of inclusion and support, participating in internal improvement projects and department activities.

Your future team

In the Global Regulatory Strategy function, we are progressing Lundbeck’s development projects and further developing strategic brands. We do that by driving innovative regulatory strategies via combining regulatory proficiency with scientific insights, patients’ focus, solid business understanding and matrix leadership.

The Global Regulatory Strategy consists of 3 teams: Regulatory Strategy Leads; Regulatory Science & Policy and Regulatory CMC.

The position is placed in Valby, Denmark. Hybrid working option may be considered depending on your residence country.

What you bring to the team

To be qualified for this role, you need:

• University credentials in life science or medical discipline; PhD degree is an advantage
• Profound experience with global regulatory strategies, including hands-on health authority interactions and global new drug applications.
• High degree of scientific and value chain understanding allowing you to challenge beyond the regulatory field.

• • Scientific understanding and knowledge from drug development of CNS, biologics and/or rare diseases is a clear advantage.

• Innovative mindset combined with solid matrix leadership skills and ability to influence on all levels of organization.
• Advanced communication skills in written and spoken English.

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, please contact Magdalena Jayatissa, VP Head of Global Regulatory Strategy by majy@lundbeck.com.

Applications must be received by November 30, 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.