Director, Global Regulatory Affairs, Pediatrics
Core
Director leading global pediatric regulatory strategy for Virology, Oncology, and Inflammation products to secure licensure and optimize development pathways.
Role type
Senior Director, Global Regulatory Affairs (Pediatrics)
Builds
Global pediatric regulatory plans and submissions for medicinal products
Domain
Life Sciences / Pharmaceutical Regulatory Affairs
Required skills
Pediatric drug development strategy, Regulatory submissions (US/EU), ICH guidelines, Cross-functional leadership, Risk assessment, Negotiation with health authorities
Preferred skills
Pediatric regulatory mechanisms (Orphan/Fast Track), Gilead therapeutic area experience, Full lifecycle drug development
Technologies
Regulatory filing systems, Project management tools
Responsibilities
Develop and deliver global pediatric regulatory strategy; Provide leadership on pediatric requirements in major markets; Identify and mitigate pediatric regulatory risks; Represent company in negotiations with regulatory authorities; Lead process improvements for regulatory compliance.
Seniority
Director, strategic leadership & cross-functional alignment