Senior Director, Global Regulatory Strategy

Leo Pharma • Madison, WI

35d • $183,000 - $260,000

About The Position

Are you a seasoned regulatory expert with a passion for shaping innovative strategies to drive global drug development and market access? LEO Pharma is looking for a Senior Director, Global Regulatory Strategy to take ownership of end-to-end regulatory strategies for our assets, ensuring they align with our mission to improve the lives of patients worldwide. In this pivotal role, you will spearhead early regulatory strategies, shape pathways for emerging assets, build strong relationships with health authorities, and drive high-impact submissions across top 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. As Senior Director, Global Regulatory Strategy, you will be at the helm of crafting strong yet bold regulatory strategies, uniting cross-functional expertise, and forging partnerships and close interaction with health authorities to accelerate fast-track breakthrough therapies in line with LEO Pharma's mission.

Requirements

• 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.
• Mastery of global regulatory landscapes, including FDA, EMA, PMDA, and NMPA.
• Expertise in regulatory labeling development, expedited programs and CTD excellence.
• Proven ability to lead Health Authority interactions and manage high-quality regulatory submissions (e.g. MAAs, NDAs, and other global filings).
• Demonstrated success in integrating regulatory strategies into early clinical and CMC development plans, including biomarkers, dose and regimen rationale, and device/diagnostics considerations.
• 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.
• Financial acumen to drive resource trade-offs and align business and regulatory objectives.
• Resilience and adaptability to thrive in a dynamic, fast-paced environment.

Nice To Haves

• Dermatology, immunology, and/or prior rare disease experience is strongly preferred

Responsibilities

• Setting the foundation for pivotal development by defining regulatory plans for assets through early phases (e.g., preclinical, First-in-Human to End-of-Phase 2).
• Defining global regulatory pathways across key markets (US, EU, JP, CN), including strategies for expedited programs and labeling aligned with TPPs (Target Product Profiles).
• Leading health authority engagement, including but not limited to pre-IND, Scientific Advice, and PRIME interactions.
• Lead submission excellence and readiness across CMC, clinical, and nonclinical content for global filings
• Leading early regulatory risk identification, scenario planning, and evidence integration to anticipate risks, strengthen development plans,and align teams and leadership on approvability success .
• Champion patient‑driven regulatory strategies by embedding insights, feasibility, and endpoints, while staying ahead of global regulatory trends to steer policy, guide governance, and align cross‑functional teams
• Co-presenting evidence-based regulatory recommendations and risk/benefit trade-offs to governance boards, translating decisions into regulatory roadmaps for the Global Project Team (GPT).
• Apply your solid regulatory expertise to guide Business Development due diligence with sharp, early assessments of promising new assets
• Being a pivotal force in advancing asset strategy within a high‑performing Global Program Team where regulatory leadership powers innovation, alignment, and results.

Benefits

• LEO Pharma offers a competitive benefits package including medical, dental, and vision coverage, employer-paid life and disability insurance, a 401(k) retirement plan with employer match; and paid time off.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree