Kevin Smyth Email Address

Senior Vice President, Regulatory Affairs and Quality

PaxVax is a leading independent vaccine company devoted to developing and commercializing specialty vaccines that protect against existing and emerging infectious diseases.

Executive who excels at leading global regulatory strategy and who has guided drug candidates from preclinical studies to commercialization in less than five years. Consistently win timely approvals for world-wide Clinical Trial Applications and Market Applications submitted to the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), the Japanese Pharmaceuticals and Medical Devices Agency (PMDA), and into AsiaPac and LatAm. Strong builder and leader of the Regulatory Affairs, Quality Assurance, Quality Control, and Pharmacovigilance functions, each of which delivers high-quality results on-schedule and on-budget. - Start-up Biotech and Pharma Companies - Provide functional vision, strategy, leadership - Multi-functional knowledge and experience - Win global CTA/MA approvals with Orphan - Build and lead RA/PV/QA/QC departments- Pediatric Plans; Fast-track; Priority Review