Global Regulatory Strategy Lead, Senior Director

Lundbeck; København; Hybrid; DKK 1,109,000 - 1,525,000; Full time

Job summary

Lundbeck in Denmark is seeking a Global Regulatory Strategy Lead (Senior Director) to shape global regulatory strategies across CNS development programs. This strategic individual contributor role emphasizes influence, cross-functional collaboration, and high-quality regulatory decisions.

You will partner with Global Project Teams and regulatory CMC, lead health authority engagements, and help advance innovative medicines through development and into global submissions.

Qualifications

• 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
• Advanced communication skills in written and spoken English.

Responsibilities

• Shape and lead global regulatory strategies across major markets.
• Influence critical development decisions with cross-functional teams and governance bodies.
• Drive strategic Health Authority engagement and translate feedback into development plans.
• Lead through influence and align diverse experts across regions to high-quality decisions.
• Contribute to shaping the future of the Global Regulatory Strategy function.

Skills

Regulatory strategy

Regulatory project management

Leadership influence

Communication skills

Education

Life science or medical degree

PhD degree (advantage)

Job description

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.

• 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

To be qualified for this role, you need:

• 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.

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.

Applications must be received by 8 November 2026.

Learn more about us at www.lundbeck.com, LinkedIn or Instagram (@h_lundbeck).

#EveryBrainInTheGame