Regulatory Affairs Director
Core
Provides strategic and operational regulatory leadership for the development, commercialisation, and life cycle management of assigned product(s), serving as the global or regional regulatory lead.
Role type
Senior IC Regulatory Affairs Director (Global/Regional Lead)
Builds
Global regulatory strategy, NDA/IND/CTA submissions, and health authority interactions for pharmaceutical products.
Domain
Life Sciences / Pharmaceutical Regulatory Affairs
Required skills
Strategic thinking, regulatory strategy formulation, health authority engagement, cross-functional team leadership, risk assessment, dossier construction, labeling negotiations, product maintenance compliance.
Preferred skills
Phase 3 design experience, end of phase 2 health authority interactions, leading response teams, emerging market regulatory knowledge.
Technologies
NDA, IND/CTA, GRST, GPT
Responsibilities
Lead development and implementation of regional or global regulatory strategy; lead cross-functional teams in major health authority interactions; lead the Global Regulatory Strategy Team (GRST); represent Regulatory Affairs on Global Product Teams; deliver regulatory milestones and assess probability of success; initiate and deliver key regulatory documents and plans; lead negotiations with health authorities; update senior management on project risks; ensure appropriate planning of global dossiers and core prescribing information; partner with marketing companies to influence developing views/guidance.
Seniority
Senior, hands-on IC with strategic leadership