Director, Regulatory Affairs Liaison, Vaccines & Infectious Diseases
Core
Develop and implement global regulatory strategy for vaccines and infectious disease products to optimize labeling and achieve shortest time to approval.
Role type
Director, Global Regulatory Affairs
Builds
Regulatory strategies and marketing applications for vaccines and infectious disease therapeutics
Domain
Pharmaceuticals / Vaccines / Infectious Diseases
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Regulatory strategy development, Regulatory Affairs Management, Clinical Trial Planning, Medical Writing, Regulatory Intelligence, Leadership, Cross-Functional Collaboration, Biological Sciences, Clinical Judgment, Pharmacovigilance
Preferred skills
Experience with antibacterial, antifungal, or antiviral agents, Therapeutic area experience in vaccines or infectious diseases
Technologies
None stated
Responsibilities
Provide regulatory oversight as the single global point of contact for assigned products, Develop worldwide product regulatory strategy to optimize label and obtain shortest time to approval, Provide expert advice to Product Development Teams on regulatory issues throughout the drug life cycle, Lead cross-functional efforts to prepare for advisory committees and represent the company with external organizations like the FDA, Review and provide final approval of Worldwide Marketing Applications and Clinical Study Reports, Coordinate interactions with foreign agencies and subsidiary registration departments, Participate in regulatory due diligence activities for licensing candidate review