Mike currently serves as the Vice President Regulatory Affairs at Z-Alpha Therapeutics. Prior to joining Z-Alpha, he held multiple leadership roles, including Vice President Global Regulatory Affairs at Telix Pharmaceuticals (ASX: TLX, NASDAQ: TLX). He has led various submissions of NDA, NDS, BLA, DMF and MAA applications. Mike was the regulatory lead and point of contact for the US approval of Illuccix®. Prior to this he was responsible for Regulatory Affairs and Quality at Zevacor Molecular. Mike has overseen quality management system development and has successfully led radiopharmaceutical US pre-approval inspections. Mike brings over 15 years of experience in pharmaceutical development from early stage to commercial approval and holds a BS in Chemistry from George Mason University and MS in Regulatory Affairs from San Diego State University.
Michael Wardach
