Senior Regulatory Affairs Director- Infectious Diseases
Core
Lead global regulatory strategy for complex infectious disease products to secure rapid approval and meet business/patient needs.
Role type
Senior Regulatory Affairs Director (Global Regulatory Lead)
Builds
Global regulatory dossiers, core prescribing information, and commercialization strategies for high-profile development programs.
Domain
Pharmaceuticals / Infectious Diseases
Required skills
Global regulatory science expertise, drug development lifecycle management, cross-functional leadership, regulatory risk planning, health authority interaction management, strategic program management, in-license/due diligence review, regulatory environment monitoring.
Preferred skills
Infectious Diseases therapeutic area experience, advanced science degree, experience leading major health authority interactions (FDA advisory committees, Pre-NDA/BLA, EOP2 meetings).
Technologies
Regulatory strategy tools, dossier construction platforms, risk management frameworks.
Responsibilities
Develop and implement global regulatory strategies ensuring rapid approval; lead planning and construction of global dossiers; conduct regulatory risk planning and mitigation; serve as single point of contact for Global Regulatory Affairs on Product Development Teams; lead Global Regulatory Sub-team to incorporate regional needs; deliver regulatory milestones and assess success probabilities; partner with marketing to shape Health Authorities' views; lead regulatory staff on complex projects; ensure effective representation at health authority meetings; monitor regulatory environment changes and advise Global Product Teams; provide leadership in product in-license/divestment reviews; lead projects to improve regulatory efficiencies.
Seniority
Senior, strategic leadership & mentorship