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