Global Regulatory Strategy Lead

Lundbeck A/S, H; København; Ibrido; DKK 786.000 - 1.081.000; Tempo pieno

Descrizione del lavoro

Lundbeck A/S in Valby, Denmark, is seeking a Global Regulatory Strategy Lead to shape and drive regulatory strategy for CNS development programmes, coordinating execution for a Phase 2 programme.

You will represent Regulatory Affairs in global cross-functional teams, lead the RAFT, and have the opportunity to lead an early phase programme. Hybrid working options may be considered based on residence.

Competenze

• University degree in life science or medical discipline; PhD welcomed but not essential.
• Experience developing global regulatory strategies with health authorities.
• Broad understanding of science and drug development.
• Innovative mindset with matrix leadership and influence across the organisation.
• Advanced written and spoken English proficiency.

Mansioni

• 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 partnerships across disciplines.
• Lead the Regulatory Focus Team (RAFT) to advance development and plan regulatory activities with health authorities.
• Have the opportunity to lead an early phase programme.
• Provide regulatory insight and scientific perspectives to key decisions and risk mitigation.
• Contribute to clinical development plans and cross-l lifecycle discussions.

Conoscenze

Regulatory strategy

Matrix leadership

Stakeholder influence

English communication

Formazione

University degree in life science or medical discipline

PhD welcomed but not essential

Descrizione del lavoro

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

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.

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.

This job ad is intended for individuals seeking a career opportunity with Lundbeck. We engage with recruitment and search firms where needed on the basis of a written agreement, and we do not accept unsolicited requests of any kind. If you work as a recruitment consultant, you are kindly instructed to refrain from contacting Lundbeck or the hiring manager directly with suggested candidates. If you violate this policy, you do so at your own risk and for your own account, and Lundbeck will not assume any liability nor pay any associated fees resulting from such violation.

Applications must be received by 15 November 2026.

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.