Global Regulatory Program Lead

Application deadline:
Location:
Ballerup 2750, , Denmark

Contract type:
Permanent

Job ID:
4015

Role Description

Are you a seasoned regulatory affairs leader with a deep understanding of rare diseases and a proven track record of driving global submission strategies and regulatory approvals? LEO Pharma is seeking an experienced and ambitious Global Regulatory Program Lead to define and execute pivotal regulatory strategies, ensuring that innovative treatments for 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 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 medicine.

Your Role
As a Global Regulatory Program Lead, you will be a key driver of regulatory success for our most important assets, ensuring strategic alignment, timely approvals, and favorable outcomes in global markets.

Your key responsibilities will include:

• Designing and implementing comprehensive regulatory programs from early development stage, i.e. Phase II through approval and lifecycle management, with a particular focus on rare diseases.
• Defining global regulatory pathways for key markets (US, EU, JP, CN), including label strategies.
• Leading Health Authority (HA) engagement, including pre-IND/Scientific Advice meetings and PRIME/Breakthrough designation pathways to 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 strategies into program plans to mitigate challenges.
• Spearheading orphan drug/expedited routes and lifecycle management strategies, including new indications, global label harmonizations, and extensions.
• Collaborating across functions such as Clinical, Biostats, Safety/PV, Market Access, and Commercial to align regulatory inputs with holistic development strategies.
• Ensuring evidence strategy includes natural history studies, external controls, registries, and patient advocacy insights for rare disease programs.
• 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.
• Mastery of global regulatory pathways (FDA, EMA, PMDA, and NMPA) and proficiency with rare disease methodologies such as external controls, adaptive designs, and registries.
• Expertise within expedited pathways and orphan drug regulatory strategies.
• Proven advisory committee/CHMP experience with successful outcomes.
• Demonstrated success in leading high-quality submissions, including NDA, BLA, MAA, and ROW filings.
• Strategic and technical expertise in labeling strategies, eCTD excellence, post-marketing commitments, and regulatory roadmaps.
• 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 regulatory pathways for 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. Collaboration across Clinical, CMC, QA, Commercial, and other key internal 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.

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

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