Director, (Super) Office of Pharmaceutical Quality at U.S. Food and Drug Administration (Center for Drug Evaluation and Research) | Silver Spring, Maryland, United States
Director, (Super) Office of Pharmaceutical Quality at
U.S. Food and Drug Administration (Center for Drug Evaluation and Research)
in January 2015 to Present
Vice President, Global R&D Franchise Head, Cough/Cold/Respiratory at
Novartis Consumer Health/GlaxoSmithKline Consumer Health
in May 2013 to January 2015
Vice President and Global Head, Global Product Development at
Novartis Consumer Health/GlaxoSmithKline Consumer Health
in May 2010 to May 2013
Michael Kopcha Education
Rutgers University, Ph.D.
Rutgers University, M.S.
Rutgers University, B.S.
Michael Kopcha Skills
R&DProduct DevelopmentPharmaceutical Industry
FDARegulatory AffairsGMPTechnology TransferCross-functional Team LeadershipClinical DevelopmentLifesciencesValidationPharmaceuticsStrategyAnalytical ChemistryDrug DevelopmentRegulatory SubmissionsDrug DeliverySopBiotechnologyFormulationCAPA21 CFR Part 11Regulatory RequirementsV&VBiopharmaceuticalsGLPINDChange ControlCommercializationOncologyCROGCPPharmacovigilanceVaccinesSOPLife SciencesResearch and Development (R&D)U.S. Food and Drug Administration (FDA)
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About Michael Kopcha's Current Company
U.S. Food and Drug Administration (Center for Drug Evaluation and Research)