Director, Head of Global Nemluvio Regulatory Strategy
Core
Leads global regulatory strategy, submission planning, and health authority engagement for Nemolizumab (Nemluvio) across all approved and development-stage indications.
Role type
Director, Global Regulatory Strategy
Builds
Global regulatory outcomes for Nemolizumab across the product lifecycle
Domain
Biopharmaceuticals / Dermatology
Required skills
Global regulatory strategy, submission planning, health authority engagement, risk assessment, cross-functional leadership, international project management, FDA interaction, clinical/non-clinical/CMC documentation coordination
Preferred skills
None stated
Technologies
None stated
Responsibilities
Accountable for global regulatory strategies and submission plans for Atopic Dermatitis, Prurigo Nodularis, and new indications; Leads the Nemluvio Global Regulatory Team; Serves as primary contact for the FDA; Identifies and mitigates product development risks; Provides strategic regulatory input to development activities and documents
Seniority
Director, strategic leadership & team management