Global Regulatory Strategy Director
We are currently looking for a Global Regulatory Strategy Director 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 – why is this a great opportunity?
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, passionate colleagues and a culture characterized as collaborative – a must to successfully bring our treatments through research and development all the way to commercialization and the people who need them. We offer a mix of exciting tasks and numerous development opportunities that are balanced with initiatives focused on your well-being.
You can also learn more about us at www.lundbeck.com or by following us on LinkedIn, Instagram (@h_lundbeck) or Twitter (@Lundbeck).
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. No separate cover letter is needed. 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 Magdalena Jayatissa, VP Head of Global Regulatory Strategy by majy@lundbeck.com. Applications must be received by August 15, 2025.
We need every brain in the game – and that includes all brains and the different perspectives we bring to the table. At Lundbeck, we embrace the uniqueness of each employee, and 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.
#EveryBrainInTheGame
To external agencies: Lundbeck does not accept unsolicited requests or candidates from search firms. We ask you to respect this policy by refraining from contacting our employees about this position.
At Lundbeck, our most important contribution is easing the burden of the millions of people living with brain disorders. Whether it is migraine, depression, or other brain disorders, patients, their carers, and society as a whole depend on us.
Through cutting edge science and strong partnerships, we develop and market some of the world’s leading treatments, expanding into neuro-specialty and neuro-rare from our strong legacy within psychiatry and neurology.
The brain health challenge is real. Our commitment is real. Our impact is real.