Regulatory Affairs Director
Core
Provide strategic regulatory leadership for the development, commercialization, and life cycle management of infectious disease products (vaccines, anti-infectives) to ensure rapid global approval and competitive labeling.
Role type
Senior IC Regulatory Affairs Director (Global Strategy)
Builds
Global regulatory dossiers (BLA/MAA/IND/CTA), core prescribing information, and approved medicines for patients.
Domain
Life Sciences / Infectious Diseases / Vaccines / Anti-infectives
Required skills
Global regulatory strategy, health authority interaction, cross-functional team leadership, risk assessment, project management, regulatory submission management
Preferred skills
Vaccine or anti-infective therapy experience, FDA advisory committee or EMA oral explanation preparation, due diligence or business alliance experience
Technologies
Regulatory submission systems, dossier construction tools
Responsibilities
Develop and implement regional or global regulatory strategies; lead the construction of global dossiers and core prescribing information; lead cross-functional teams in major regulatory submissions and health authority interactions; deliver regulatory milestones including risk assessment; participate in skill-development and coaching of regulatory staff
Seniority
Senior, hands-on IC with strategic leadership
