Global Regulatory Program Lead

Field of work: Regulatory & Medical

Posting Date: 4 Dec 2025

Application deadline: 31 Dec 2025
Location: Ballerup 2750, Denmark, Denmark
Contract type: Permanent
Job ID: 3977

Role Description
Are you a seasoned regulatory affairs leader with a passion for shaping innovative strategies that set assets up for pivotal success? LEO Pharma is seeking an experienced Global Regulatory Program Lead to define and drive end-to-end early development regulatory strategies, from preclinical and First-in-Human through End-of-Phase 2, laying the foundation for approvability and future market access in dermatology and immunology, ensuring they align with our mission to improve the lives of patients worldwide.

This is more than just a role. It is an opportunity to be at the forefront of dermatology innovation and regulatory excellence, shaping the future of healthcare and improving the lives of patients. You will spearhead early regulatory strategies, unlock expedited pathways for emerging assets, build strong relationships with health authorities, and ensure robust development of differentiated assets across global markets.

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 an Early Development Global Regulatory Program Lead, you will play a crucial role in the stewardship of Leo Pharma’s pipeline, crafting strong evidence-based regulatory strategies for emerging assets , uniting cross-functional expertise, and forging partnerships and close interaction with health authorities to secure strategic clarity and speed. You will define global regulatory pathways, position programs for expedited designations, orchestrate IND/CTA excellence, and embed early risk identification and translational evidence to strengthen program plans ahead of pivotal development.

Your key responsibilities will include:

• Setting the foundation for pivotal development by defining regulatory strategy for assets through early phases (e.g., preclinical, First-in-Human to End-of-Phase 2).
• Designing and implementing comprehensive early development regulatory programs across key markets (US, EU, JP, CN), spanning preclinical, First-in-Human, Phase I/II, and End-of-Phase 2 decision points.
• Defining innovative development pathways, including positioning for expedited programs (e.g., Fast Track, Breakthrough Therapy, PRIME), aligned to evolving Target Product Profiles (TPPs) and downstream labeling considerations.
• Leading Health Authority engagement early in development (e.g., pre-IND/IMPD advice, Scientific Advice, PRIME) to secure strategic clarity on program design, endpoints, and evidence packages.
• Planning and executing early-phase submissions (INDs/CTAs), ensuring high-quality clinical, nonclinical, and CMC content and readiness for global filings as programs progress.
• Identifying regulatory risks and opportunities early; developing scenario plans and decision frameworks that shape study designs, dose/regimen selection, and biomarker strategies supporting approvability.
• Championing and embedding patient-driven insights, feasibility, and endpoints into early clinical and regulatory strategy; providing cross-functional teams (Clinical, CMC, QA, Commercial) and governance with clear, evidence-based recommendations
• Applying strategic regulatory expertise to inform Business Development due diligence with robust assessments of promising new assets & providing leadership in enabling seamless integration of acquired assets
• Ownership and accountability in advancing asset strategy within a high‑performing Global Program Team where regulatory leadership powers innovation, alignment, and results.

Your Qualifications

To succeed in this role, you should bring:

• An advanced degree in a scientific field (PharmD, PhD, MD, or equivalent).
• 10+ years’ experience in regulatory affairs, with a proven track record in IND/CTA submissions and early Health Authority engagements.
• Proven global strategic expertise (FDA, EMA, PMDA, NMPA) adept at integrating early strategy with downstream approval and access considerations.
• Demonstrated ability to embed translational elements (biomarkers, dose/regimen rationale, device/diagnostics) into early clinical and CMC plans.Proven ability to lead Health Authority interactions in early development phases.
• Strong communication skills to distill complex scientific issues into actionable recommendations for governance and external stakeholders.
• Matrix leadership with an enterprise mindset, high emotional intelligence (EQ), and critical thinking to influence cross-functional teams and optimize plans.
• Resilience and adaptability to thrive in a dynamic, fast-paced, environment.

Your New Team

You will work closely with the Global Program Head and Global Program Teams (GPTs) to build and deliver coherent, forward-looking early development regulatory strategies. A highly visible and collaborative leader, you will partner with enterprise stakeholders and external Health Authorities and industry bodies to drive impactful decisions 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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