Senior Regulatory Affairs Director- Infectious Diseases
Core
Lead global regulatory strategy for complex infectious disease products to secure rapid approval and meet business and patient needs.
Role type
Senior Regulatory Affairs Director (Global Regulatory Lead)
Builds
Global regulatory dossiers, core prescribing information, and commercialization strategies for vaccines and antibodies.
Domain
Biopharmaceuticals / Infectious Diseases
Required skills
Global regulatory science, drug development processes, strategic leadership, risk planning and mitigation, cross-functional collaboration, health authority interaction, program management
Preferred skills
Infectious Diseases experience, advanced degree in science-related field
Technologies
Regulatory strategy documents, global dossier construction tools
Responsibilities
Lead or deputise for VP in senior-level internal and external interactions; Develop and implement 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; Lead Global Regulatory Sub-team; 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; Provide leadership in in-license/due diligence and divestment reviews; Lead projects to improve efficiencies.
Seniority
Senior, strategic leadership & mentorship