Global Regulatory BD Lead – Drug Dev Strategy

LEO Pharma; Ballerup; Hybrid; 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

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