Regulatory Affairs Director
Core
Provide strategic and operational regulatory leadership for the development, commercialization, and life cycle management of oncology products.
Role type
Senior IC Regulatory Affairs Director (Oncology)
Builds
Global regulatory strategies, major submissions (NDA/BLA/IND/CTA), and health authority engagement plans for oncology therapies.
Domain
Pharmaceuticals / Oncology
Required skills
Regulatory strategy, health authority interaction, clinical strategy development, risk evaluation, team leadership, dossier construction, label negotiations
Preferred skills
Oncology therapeutic area experience, radio-conjugate development, Phase 3 design, statistical design knowledge, benefit/risk profiling
Technologies
NDA, BLA, IND, CTA, briefing documents, global dossiers
Responsibilities
Lead cross-functional teams in major regulatory submissions; craft and implement regional or global regulatory strategies; lead health authority engagement strategies and meetings; mentor the Global Regulatory Strategy Team; deliver regulatory milestones and risk assessments; negotiate with health authorities; plan and construct global dossiers and prescribing information.
Seniority
Senior, hands-on IC with strategic leadership