Global Regulatory Strategy Lead

Lundbeck; København; Hybrid; DKK 786,000 - 1,081,000; Full time

Job summary

Lundbeck is seeking a Global Regulatory Strategy Lead in Copenhagen to shape and drive the global regulatory plan for a Phase 2 CNS programme. You will coordinate execution across functions and lead the Regulatory Focus Team to advance development and interactions with health authorities.

You will bring regulatory insight to key project decisions, explore innovative approaches, contribute to clinical development plans, and help teams balance opportunities and risks across the development

Qualifications

• Experience shaping global regulatory strategies for drug development.
• Interactions with health authorities and regulatory bodies.
• Strong cross-functional collaboration and leadership.
• Advanced written and spoken English.

Responsibilities

• Shape and drive the global regulatory strategy for a Phase 2 programme.
• Represent Regulatory Affairs in a global cross-functional project team.
• Lead the Regulatory Focus Team (RAFT) coordinating regulatory experts.
• Contribute to clinical development plans and regulatory risk mitigation.

Skills

Regulatory strategy development

Global regulatory interactions

Cross-functional leadership

English communication

Education

University degree in life science/medical discipline

PhD welcome (not essential)

Job description

Global Regulatory Strategy Lead – shape regulatory strategy for new CNS treatments

Requisition ID: 8168

Location:

Copenhagen, Danish Capital Region, DK

Your new role

In this role, you will:

• Shape and drive the global regulatory strategy and coordinate its execution for a Phase 2 development programme




• Represent Regulatory Affairs in a global, cross-functional project team and build strong partnerships across disciplines




• Lead the Regulatory Focus Team (RAFT) bringing together regional regulatory leads, regulatory CMC and other regulatory experts to advance development, plan and prepare all regulatory activities and interactions with health authorities




• Have the opportunity to lead an early phase programme

You will also:

• Bring regulatory insight and scientific perspective to key project decisions




• Explore innovative, evidence-based regulatory approaches




• Contribute to clinical development plans and discussions across the development lifecycle




• Identify regulatory risks, assess options and recommend mitigating actions,




• Help teams make informed decisions by creating clarity, engaging stakeholders and balancing opportunities and risks




• Share knowledge, support colleagues and contribute to an inclusive team culture and continuous improvement across Global Regulatory Strategy

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:

• A University degree in life science or medical discipline; A PhD degree is welcome but not essential




• Experience developing global regulatory strategies, including interactions with health authorities and involvement in global new drug applications




• A broad understanding of science and drug development, with curiosity about perspectives beyond Regulatory Affairs




• Innovative mindset combined with solid matrix leadership skills and ability to influence on all levels of organisation.




• Advanced communication skills in written and spoken English.

Our promise to you

Lundbeck offers an inspiring workplace, passionate colleagues and a culture characterised as collaborative – a must to successfully bring our treatments through research and development all the way to commercialisation 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.

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 .

Annual base salary range: 786 000 - 1 081 300 DKK gross

At Lundbeck, we are committed to fair and transparent pay. Please note that the final base salary within the stated range will be based on relevant qualifications, skills, competencies, and level of proficiency as well as internal pay equity.

If you have questions or want to hear more, please feel free to contact hiring manager Ann-Lisbeth Aarup Nielsen, [e-mail] .

Applications must be received by 15 November 2026.

Learn more about us at www.lundbeck.com ,LinkedIn (https://www.linkedin.com/company/lundbeck/) or Instagram (@h_lundbeck).

#EveryBrainInTheGame

About Lundbeck

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.