Regulatory Business Development Lead

Leo Pharma GmbH; Ballerup; On-site; DKK 597,015 - 895,522; Full time

Job summary

Leo Pharma GmbH, located in Ballerup, Denmark, is seeking a Regulatory Business Development Lead. This role involves supporting identification and evaluation of external innovation opportunities, ensuring robust regulatory assessments to meet business development goals.

The ideal candidate will possess an advanced degree and 10 years of regulatory experience in the pharmaceutical industry. A hybrid work setup is available, allowing contribution from various locations across Europe.

Qualifications

• 10 years of global regulatory experience in the pharmaceutical or biotech industries.
• Proven track record in driving business development regulatory excellence.
• In-depth knowledge of global regulatory systems and pathways.

Responsibilities

• Provide expert regulatory input into portfolio and pipeline strategy.
• Lead regulatory due diligence activities.
• Conduct comprehensive global regulatory assessments.
• Identify regulatory risks and develop mitigation strategies.
• Deliver regulatory risk-benefit assessments to governance bodies.

Skills

Regulatory input expertise

Due diligence experience

Regulatory risk assessment

Strategic mindset

Collaboration with Health Authorities

Education

Advanced degree in scientific field

Job description

Role Description

Join us in creating a future legacy in medical dermatology

At LEO Pharma, we are global leaders in medical dermatology. We have 115 years’ experience in bringing innovation to healthcare. And we are eager to do much more. Each year, close to 100 million people have a better day because of our medicines.

In Global Regulatory Affairs we share a “challenge accepted” mindset and are guided by our winning behaviours of simplification, collaboration, and accountability, to achieve our goals.

Your role

As a Regulatory Business Development Lead, you will support the identification, evaluation, and progression of external innovation opportunities, ensuring robust regulatory assessments, clear value‑creation perspectives, and efficient use of internal expertise to support LEO Pharma’s business development goals.

Your key responsibilities include:

• Providing expert regulatory input into portfolio and pipeline strategy, evaluation, and acceleration.
• Leading the planning and execution of regulatory due diligence activities across internal and external assets.
• Conducting comprehensive global regulatory assessments covering clinical, nonclinical, CMC, and regional requirements.
• Identifying regulatory risks, gaps, and opportunities, and developing mitigation strategies to maximise the probability of technical and regulatory success.
• Driving efficient, structured due diligence processes to optimise resource use across the portfolio.
• Delivering clear regulatory risk‑benefit assessments and actionable recommendations to governance bodies.
• Partnering with Search & Evaluation and Business Development teams to embed regulatory insights into deal strategy and valuation.
• Engaging with external partners and Health Authorities.
• Contributing to the development of best practices for regulatory involvement in business development and asset evaluation.

To succeed in this role, we imagine that you have the following qualifications:

• Advanced degree in a scientific field (PharmD, PhD, MD, MSc).
• 10 years of global regulatory experience in the pharmaceutical or biotech industries.
• Proven track record in driving business development regulatory excellence within a search and evaluation development model.
• Demonstrated expertise in due diligence activities, regulatory risk assessment, and pipeline‑building initiatives.
• In‑depth knowledge of global regulatory systems and pathways.
• Experience collaborating with external partners, Health Authorities, and cross‑functional teams.
• Strategic and operational mindset with the ability to navigate fast‑paced environments and balance multiple priorities and proven problem‑solving capability within drug development.

While this position is based in our HQ in Denmark, we are also open to a hybrid work setup across Europe, enabling you to contribute from your location while fostering close collaboration with the global team.

If this exciting opportunity aligns with your expertise, we’d love to hear from you!

We value diversity and welcome applications from all qualified candidates, recognizing that our different perspectives, backgrounds, and attitudes enable us to make the best decisions.

For certain positions, LEO Pharma might complete a background check conducted by a third party.