Global Regulatory Strategy Lead

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

Job summary

Lundbeck is seeking a Global Regulatory Strategy Lead to shape the strategy for a Phase 2 CNS development programme and coordinate its execution. The role requires representing Regulatory Affairs in a global project team and leading the RAFT to advance development and plan regulatory interactions with health authorities.

You will contribute regulatory insight to key decisions, explore innovative approaches, and help shape development plans across the lifecycle.

Qualifications

• University degree in life science or medical discipline (PhD welcome but not essential).
• Experience developing global regulatory strategies, including interactions with health authorities.
• Involvement in global new drug applications and regulatory submissions.
• Broad understanding of science and drug development with curiosity beyond Regulatory Affairs.
• Innovative mindset with matrix leadership and ability to influence at all levels.
• Advanced communication skills in English (written and spoken).

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) with regional leads and other experts.
• Opportunity to lead an early phase programme.
• Support decision making by providing regulatory insights and risk assessments.

Skills

Matrix leadership

Communication

English proficiency

Education

Life science degree

PhD welcomed

Job description

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

We are currently looking for a Global Regulatory Strategy Lead to join the Global Regulatory Strategy Leads (current 15 leads) team to work on development project(s) aiming at providing new treatment to patients with CNS diseases.

Your new role

• 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 atlundbeck/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.

Applications must be received by 15 November 2026.