Regulatory Business Development Lead

LEO Pharma; Ballerup; On-site; DKK 900,000 - 1,300,000; Full time

Benefits offered by this job

Hybrid work Europe

Job summary

LEO Pharma, a global leader in dermatology, seeks a Regulatory Business Development Lead to drive regulatory input for portfolio strategy and external innovation opportunities. You will guide due diligence activities, assess global regulatory requirements, and collaborate with internal and external partners to maximize deal value.

The role emphasizes strategic thinking, cross-functional leadership, and strong regulatory expertise in a fast-paced environment across Europe, with hybrid work

Qualifications

• Advanced degree in a scientific field (PharmD, PhD, MD, MSc).
• 10 years of global regulatory experience in pharmaceutical/biotech industries.
• Proven track record in driving regulatory excellence within a search & evaluation model.
• Experience with due diligence, regulatory risk assessment and pipeline-building.
• Deep knowledge of global regulatory systems and pathways.
• Experience collaborating with Health Authorities and external partners.

Responsibilities

• Provide expert regulatory input into portfolio and pipeline strategy.
• Lead planning and execution of regulatory due diligence across assets.
• Conduct global regulatory assessments for clinical, nonclinical, CMC and regional needs.
• Identify risks, gaps and opportunities, and develop mitigation strategies.
• Drive structured due diligence to optimise resource use across the portfolio.
• Deliver regulatory risk-benefit assessments and actionable recommendations to governance bodies.
• Partner with Search & Evaluation and Business Development to embed regulatory insights into deal strategy.
• Engage with external partners and Health Authorities.

Skills

Regulatory affairs

Due diligence

Strategic planning

Cross-functional leadership

Regulatory strategy

Education

PharmD/PhD/MD/MSc

Job description

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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.

Contact and Application

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.

Beyond the skin

Join LEO Pharma, a global leader in medical dermatology, as we go beyond the skin to make a lasting impact. Our innovative approach sets us apart. We are dedicated to leaving a legacy that positively impacts patients, colleagues, and our planet.

At LEO Pharma, we believe in the power of individuals to drive change. Our flat organizational structure empowers you to make a visible impact and offers versatile roles for professional growth. 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. Join our passionate team at LEO Pharma and be yourself as we work together to make a difference.

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