Global Regulatory Program Lead
Application deadline: 23 Dec 2025
Location: Ballerup 2750, Denmark, Denmark
Contract type: Permanent
Job ID: 4015
Are you a seasoned regulatory affairs leader with a deep understanding of drug development in dermatology and immunology including rare diseases and a proven track record of turning innovative strategies into best-in-industry regulatory outcomes? LEO Pharma is seeking an experienced and ambitious Global Regulatory Program Lead to define and execute pivotal regulatory strategies, ensuring that innovative treatments for dermatology and rare disease patients are brought to market effectively and efficiently.
This is more than just a role. It is an opportunity to be at the forefront of dermatology and rare disease innovation and regulatory excellence, shaping the future of healthcare and improving the lives of underserved patient populations.
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.
Your Role
As a Global Regulatory Program Lead, you will drive regulatory success for our most critical assets, ensuring strategic alignment, timely approvals, and game-changing outcomes, bringing innovation to patients across global markets.
Your key responsibilities will include:
• Designing and implementing comprehensive regulatory programs through the clinical development phases through to approval and lifecycle management, focusing on both rare and prevalent indications..
• Defining innovative global regulatory strategies and pathways for key markets (US, EU, JP, CN).
• Leading Health Authority (HA) engagement, across the development phases to deliver strategic clarity and secure expedited approvals.
• Planning and executing global submissions, managing timelines, and ensuring high-quality content across clinical, nonclinical, and CMC modules.
• Addressing regulatory risks and opportunities, developing evidence-based scenarios, and embedding regulatory strategies into actionable program plans.
• Demonstrating leadership and regulatory affairs strategic and operational excellence in a dynamic Search & Development patient-focused environment.
• Collaborating across the enterprise to address development challenges and develop differentiated ‘game-changing’ assets .
• Monitoring global regulatory trends, competitor activities, and HA guidance, incorporating findings into internal policies and governance discussions.
• Representing regulatory affairs in Global Program Teams (GPTs) and governance discussions, ensuring clear, evidence-based recommendations and alignment.
Your Qualifications
To excel in this role, you should bring:
• An advanced scientific degree (PharmD/PhD/MD or equivalent).
• 12–15+ years of regulatory leadership experience, including multiple successful regulatory filings and approvals.
• Track record of successful delivery of global regulatory outcomes (FDA, EMA, PMDA, and NMPA) and demonstrated proficiency enabling access strategies using expedited regulatory pathways for both prevalent and rare diseases.
• Expertise with expedited regulatory pathways and regulatory strategies.
• Strong matrix leadership and cross-functional collaboration skills across geographies and functions.
• Highly developed communication and negotiation skills with Health Authorities and internal governance.
• Experience in dermatology and immunology drug development as well as rare diseases (preferred).
Your New Team
You will work closely with the Global Program Head and Global Program Teams (GPTs) for your assigned asset to build and deliver coherent, forward-looking regulatory strategies. A highly visible and collaborative leader working with enterprise stakeholders alongside external interactions with Health Authorities and Industry bodies will enable you to drive impactful decision-making and deliver innovative therapies to patients globally.
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.
If this exciting opportunity aligns with your expertise, we’d love to hear from you!
You do not need to upload a cover letter, but feel free to include a few sentences in your CV about why this position excites you. Please refrain from adding a photo to your CV.
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.
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