Global Regulatory Strategy Lead, Senior Specialist with focus on Asia strategy and LCM

Global Regulatory Strategy Lead, Senior Specialist with focus on Asia strategy and LCM

We are currently looking for a Global Regulatory Strategy Lead to join the Global Regulatory Strategy Leads team (currently 10 leads) to work on a late-stage development project aiming at providing new treatment to patients with neurological disorder with high unmet need.  

Your new role – why is this a great opportunity?

In this role, you will take responsibility for strengthening the connectivity and alignment between global regulatory strategy and local registration requirements in Japan and China. In addition, you will be responsible for progressing regulatory activities related to life cycle management of this drug. The LCM activities are initiated in advance of new drug submission /approvals to obtain the full potential for the medicine’s offering to the patients.

In your role you will be a part of Regulatory Focus Team (RAFT) and work very closely with Global Regulatory Strategy Lead and the regional regulatory leads in Japan and China as well as the RA CMC Lead to progress development and registration activities as well as plan registration-enabling health authorities’ interactions. In the project context, you will be working in a matrix organization with a variety of cross-functional stakeholders including clinical leads, biostatisticians, data scientists and medical writers.

In collaboration with the Global regulatory Strategy Lead, you will be expected to provide strategic input and regulatory expertise, work on innovative regulatory strategies, define regulatory tactics including planning Health Authorities interactions, provide input to clinical development plans, evaluate regulatory risks, and recommend mitigating actions.

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 Department 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.
• Experience with global regulatory strategies, including hands-on health authority interactions and global new drug applications.
• Scientific and value chain understanding.
• 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 Trine Oesterby, Global Regulatory Strategy Lead at tros@lundbeck.com.

Applications must be received by 1 May 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.