LEO Pharma
Senior Director, Global Regulatory Strategy
Join LEO Pharma – a global leader in medical dermatology – as Senior Director, Global Regulatory Strategy. Job Summary
In this pivotal role, you will take ownership of end‑to‑end regulatory strategies for LEO Pharma assets, shaping pathways, engaging health authorities, and driving high‑impact submissions across global markets. Responsibilities
Setting the foundation for pivotal development by defining regulatory plans for assets through early phases (preclinical, First‑in‑Human to End‑of‑Phase 2). Defining global regulatory pathways across key markets (US, EU, JP, CN), including expedited programs and labeling aligned with TPPs. Leading health authority engagement, including pre‑IND, Scientific Advice, and PRIME interactions. Leading 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 and align teams. Champion patient‑driven regulatory strategies embedding insights, feasibility, and endpoints. Co‑presenting regulatory recommendations and risk/benefit trade‑offs to governance boards. Guiding Business Development due diligence with early assessments of new assets. Serving as a pivotal force in advancing asset strategy within a high‑performing Global Program Team. Qualifications
Advanced degree in a scientific field (PharmD, PhD, MD, or equivalent). 10+ years’ experience in regulatory affairs, with a track record in IND/CTA submissions and early Health Authority engagements. Mastery of global regulatory landscapes (FDA, EMA, PMDA, NMPA). Experience in dermatology, immunology, or rare disease preferred. Expertise in regulatory labeling development, expedited programs, and CTD excellence. Proven ability to lead Health Authority interactions and manage high‑quality regulatory submissions. Success integrating regulatory strategies into early clinical and CMC development plans. Strong communication skills to distill complex scientific issues into actionable recommendations. Matrix leadership with enterprise mindset, high EQ, critical thinking. Financial acumen to drive resource trade‑offs. Resilience and adaptability to thrive in dynamic environment. Benefits
The base salary range is $183,000–$260,000 per year. LEO Pharma offers competitive benefits including medical, dental, vision, life and disability insurance, a 401(k) with employer match, and paid time off. Work may be hybrid. Equal Opportunity
LEO Pharma Inc. is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration regardless of protected characteristics.
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Join LEO Pharma – a global leader in medical dermatology – as Senior Director, Global Regulatory Strategy. Job Summary
In this pivotal role, you will take ownership of end‑to‑end regulatory strategies for LEO Pharma assets, shaping pathways, engaging health authorities, and driving high‑impact submissions across global markets. Responsibilities
Setting the foundation for pivotal development by defining regulatory plans for assets through early phases (preclinical, First‑in‑Human to End‑of‑Phase 2). Defining global regulatory pathways across key markets (US, EU, JP, CN), including expedited programs and labeling aligned with TPPs. Leading health authority engagement, including pre‑IND, Scientific Advice, and PRIME interactions. Leading 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 and align teams. Champion patient‑driven regulatory strategies embedding insights, feasibility, and endpoints. Co‑presenting regulatory recommendations and risk/benefit trade‑offs to governance boards. Guiding Business Development due diligence with early assessments of new assets. Serving as a pivotal force in advancing asset strategy within a high‑performing Global Program Team. Qualifications
Advanced degree in a scientific field (PharmD, PhD, MD, or equivalent). 10+ years’ experience in regulatory affairs, with a track record in IND/CTA submissions and early Health Authority engagements. Mastery of global regulatory landscapes (FDA, EMA, PMDA, NMPA). Experience in dermatology, immunology, or rare disease preferred. Expertise in regulatory labeling development, expedited programs, and CTD excellence. Proven ability to lead Health Authority interactions and manage high‑quality regulatory submissions. Success integrating regulatory strategies into early clinical and CMC development plans. Strong communication skills to distill complex scientific issues into actionable recommendations. Matrix leadership with enterprise mindset, high EQ, critical thinking. Financial acumen to drive resource trade‑offs. Resilience and adaptability to thrive in dynamic environment. Benefits
The base salary range is $183,000–$260,000 per year. LEO Pharma offers competitive benefits including medical, dental, vision, life and disability insurance, a 401(k) with employer match, and paid time off. Work may be hybrid. Equal Opportunity
LEO Pharma Inc. is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration regardless of protected characteristics.
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