レオ ファーマ株式会社 · 1 month ago
Senior Director, Global Regulatory Strategy
Madison, NJ
Full-time
Onsite
Director/Executive
$183K/yr - $260K/yr
10+ years expLEO Pharma is a global leader in medical dermatology, dedicated to improving the lives of patients worldwide. They are seeking a Senior Director, Global Regulatory Strategy to craft regulatory strategies for drug development and market access, ensuring alignment with the company’s mission and fostering relationships with health authorities.
Pharmaceuticals
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
Qualification
Required
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
Preferred
Dermatology, immunology, and/or prior rare disease experience is strongly preferred
Benefits
Medical, dental, and vision coverage
Employer-paid life and disability insurance
A 401(k) retirement plan with employer match
Paid time off
Company
レオ ファーマ株式会社
レオ ファーマは、皮膚疾患を持つ人々、そのご家族及び社会の利益のために標準治療の発展に貢献することを目指したグローバル企業です。1908年に創立され、大部分の株式をレオ財団が所有しています。私たちは、皮膚科学の発展のために数十年にわたって研究開発に注力し、今日ではあらゆる重症度の皮膚疾患に対応する幅広い治療法を提供しています。レオ ファーマは、デンマークに本社を置き、4,300人の従業員が世界中の何百万人もの患者さんのために貢献しています。 レオ ファーマ株式会社は、デンマークに本社を持つレオ ファーマの子会社として2010年6月に設立され、皮膚科領域に特化した、スペシャリティファーマとして日本での確固たる地位を築くべく事業活動を展開しています。 免責事項については、下記をご参照ください。 https://www.leo-pharma.jp/sns-policy
51-200 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase