Senior Director, Global Regulatory Strategy

Senior Director, Global Regulatory Strategy

Posting Date: 26 Nov 2025 •
Location: Madison, NJ 07940, United States •
Contract type: Permanent •
Job : 3978

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.

Join us in creating a future legacy in medical dermatology. At LEO Pharma, we are global leaders in medical dermatology, with 115 years of experience in bringing innovation to healthcare. Each year, close to 100 million people have a better day because of our medicines.

You will lead the crafting of bold regulatory strategies, unit the cross‑functional teams, and forge partnerships with health authorities to accelerate breakthrough therapies in line with LEO Pharma’s mission.

• Set 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).
• Define global regulatory pathways across key markets (US, EU, JP, CN), including strategies for expedited programs and labeling aligned with TPPs.
• Lead health authority engagement, including pre‑IND, Scientific Advice, and PRIME interactions.
• Ensure submission excellence and readiness across CMC, clinical, and non‑clinical content for global filings.
• Identify early regulatory risks, plan scenarios, and integrate evidence to anticipate risks and strengthen development plans.
• Champion patient‑driven regulatory strategies by embedding insights, feasibility, and endpoints, staying ahead of global regulatory trends.
• Co‑present evidence‑based regulatory recommendations and risk/benefit trade‑offs to governance boards, translating decisions into regulatory roadmaps for the Global Project Team (GPT).
• Guide Business Development due diligence with sharp early assessments of promising new assets.
• Drive asset strategy within the high‑performing Global Program Team, ensuring regulatory leadership fuels innovation, alignment, and results.

• Advanced degree in a scientific field (Pharm
  
  D, PhD, MD, or equivalent).
• 10+ years of regulatory affairs experience, with a proven record in IND/CTA submissions and early Health Authority engagements.
• Mastery of global regulatory landscapes, including FDA, EMA, PMDA, and NMPA.
• Dermatology, immunology, and/or prior rare disease experience is strongly preferred.
• Expertise in regulatory labeling development, expedited programs, and CTD excellence.
• Proven ability to lead Health Authority interactions and manage high‑quality regulatory submissions (MAAs, NDAs, and other global filings).
• Success in integrating regulatory strategies into early clinical and CMC development plans, including biomarkers, dose, 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 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.

Work closely with the Global Program Head and Global Program Teams (GPTs) to build and deliver coherent, forward‑looking regulatory strategies, collaborating across Clinical, CMC, QA, Commercial, and other internal stakeholders, as well as external interactions with Health Authorities and industry bodies to drive impactful decision‑making.

Base salary range: $183,000–$260,000 per year. Salary varies by qualifications, skills, and performance. Certain roles may earn commissions or bonuses.

Benefits: Competitive medical, dental, and vision coverage; employer‑paid life and disability insurance; 401(k) retirement plan with employer match; and paid time off.

LEO Pharma is a global leader in medical…