Global Regulatory Strategy Lead, Senior Director

Lundbeck A/S, H; København; Hybrid; DKK 1,109,000 - 1,525,000; Full time

Job summary

Lundbeck is seeking a Global Regulatory Strategy Lead, Senior Director, in Copenhagen, Denmark, hybrid option. You will shape the global regulatory direction for development programs, influence strategic decisions, and partner with cross-functional teams to drive successful regulatory outcomes.

The role requires 10+ years in R&D with 7+ years in Regulatory Affairs, strong English communication, and a PhD is advantageous. Annual base salary range is provided, with a transparent pay approach.

Qualifications

• 10+ years of R&D experience in a pharmaceutical or biotech industry.
• 7+ years of Regulatory Affairs experience.
• Experience with regulatory project management and new drug submissions/approvals.
• Scientific understanding of CNS, biologics or rare diseases is advantageous.
• Strong communication and influence across cross-functional teams.

Responsibilities

• Shape and lead global regulatory strategies supporting ambitious development objectives.
• Influence critical development decisions through regulatory perspectives.
• Challenge conventional thinking and identify innovative regulatory approaches.
• Drive strategic Health Authority engagement and translate feedback into development actions.
• Lead through influence across functions and regions to achieve aligned decisions.

Skills

Regulatory strategy

Project management

Regulatory submissions

Strategic leadership

CNS knowledge

English communication

Education

PhD in life sciences

Job description

Global Regulatory Strategy Lead, Senior Director

Requisition ID: 8201

Location: Copenhagen, Danish Capital Region, DK

Global Regulatory Strategy Lead, Senior Director

Are you an experienced regulatory leader passionate about shaping global drug development strategies and influencing critical decisions that bring innovative treatments to patients?

We are currently looking for a Global Regulatory Strategy Lead on a Senior Director level to join the Global Regulatory Strategy Leads Team (14 leads) to work on development project(s) focused on providing new treatments to patients with CNS diseases. This is a strategic individual contributor role with the opportunity to lead through influence, drive cross-functional collaboration, and shape strategic decisions without formal people leadership responsibilities.

Your new role

As a Global Regulatory Strategy Lead, you will have the opportunity to shape the global regulatory direction of one or more development projects and play an influential role in critical decisions throughout drug development.

You will be a key strategic partner to Global Project Teams and/or submission teams bringing together scientific and regulatory insights, business understanding and an innovative approach to global regulatory strategy and drug development.

In this role, you will:

• Shape and lead global regulatory strategies that support ambitious development objectives and successful regulatory outcomes across major markets.
• Influence critical development decisions, providing strategic regulatory perspectives to cross-functional teams and senior governance bodies at Lundbeck
• Challenge conventional thinking and identify innovative regulatory approaches that create opportunities, address uncertainty and accelerate development where possible.
• Drive strategic Health Authority engagement, shaping regulatory positions, leading interactions and translating regulatory feedback into actionable development strategies.
• Lead through influence, bringing together diverse expertise across functions and regions to achieve aligned, high-quality decisions.
• Anticipate regulatory challenges and opportunities, proactively addressing risks while maintaining a strong focus on overall development and business objectives.

Beyond your project responsibilities, you will contribute to shaping the future of our Global Regulatory Strategy function. You will help strengthen strategic capabilities, foster knowledge sharing and collaboration, and contribute to how we evolve as an organization.

This is a role for a regulatory leader who wants not only to deliver successful global regulatory strategies, but also to influence how innovative medicines are developed.

Your future team

Global Regulatory Strategy (GRS) is an evolving strategic function at Lundbeck, working at the intersection of science, regulatory innovation and business decision-making. We continuously challenge how regulatory strategies can create value throughout development, from early strategic choices to global submissions and approvals. GRS consists of 3 teams: Regulatory Strategy Leads; Regulatory Science & Policy and Regulatory CMC.

As a senior member of our team, you will have the opportunity to influence not only individual drug development programs but also how we build regulatory capabilities and prepare for the future of drug development. The position is placed in Valby, Denmark. Hybrid working option may be considered depending on your residence country.

What you bring to the team

• University credentials in life science or medical discipline; PhD degree is an advantage
• 10+ years’ R&D experience within a pharmaceutical or biotech industry, with 7+ years’ experience in Regulatory Affairs
• Experience with regulatory project management and new drug submissions and approvals is a must
• High degree value chain understanding allowing you to challenge beyond the regulatory field
  • Scientific understanding and knowledge from drug development within CNS, biologics and/or rare diseases is a clear advantage.
• Innovative mindset combined with sense of urgency and assertive 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).

Annual base salary range:1 109 000 - 1 524 600 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.

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.

If you have questions, please contactMagdalena Jayatissa, VP Head of Global Regulatory Strategy by [e-mail] .

Applications must be received by 8 November 2026.