Kevin M Amiri, Age 72Monsey, NY

Palm Coast, FL

Pharmaceuticals

Parexel
Senior Regulatory Affairs Consultant Validant
Regulatory Consultant Pharmabiodevice
Regulatory Affairs Consultant Sanofi Dec 2013 - Apr 2014
Regulatory Consultant, Post Marketing Cmc Pfizer Apr 2013 - Aug 2013
Regulatory Consultant Quintiles Nov 2011 - Oct 2012
Regulatory and Compliance Consultant Merck Apr 2011 - Nov 2011
Regulatory Consultant Regeneron Pharmaceuticals, Inc. Oct 2009 - Mar 2011
Regulatory Consultant Senior Manager Consultant Regulatory Affairs Jan 2009 - Jun 2009
Regulatory Consultant and Senior Manager, Ra Time Cap Labs, Inc. Feb 2007 - Jan 2009
Vice President, Scientific Affairs Genpact Pharmalink Feb 2007 - Jan 2009
Regulatory Consultant Research Pharmaceutical Services Oct 2005 - Feb 2007
Senior Consultant Del Laboratories Apr 2004 - Oct 2005
Director, Ra Merix Bioscience Oct 2002 - Apr 2004
Vp, Ra and Qa Osiris Therapeutics Mar 2001 - Oct 2002
Director, Regulatory Affairs and Quality Assurance Biospecifics Technologies Corp 1992 - 2001
Director Ra and Qa Clinical Research Associates 1990 - 1991
Consultant Melville Biologics Mar 1989 - May 1990
Qc Manager Alpharma 1983 - 1989
Lab Director Forest Laboratories Mar 1981 - Oct 1983
Director Quality Control University of Tennessee Mar 1981 - Oct 1983

Pharmaceutical Industry, Biologics, Regulatory Affairs, Fda, Supplements, Gmp, Biotechnology, Glp, Clinical Trials, Sop, Formulation, Ind, Change Control, Cro, Clinical Research, Validation, Quality Assurance, Gcp, Pharmaceutics, Regulatory Submissions, Software Documentation, Oncology, Clinical Development, Biopharmaceuticals, Pharmacovigilance, Capa, Regulatory Requirements, Medical Devices, Therapeutic Areas, Technology Transfer, Ctms, Lifesciences, Gxp, Vaccines, 21 Cfr Part 11, Aseptic Processing, Cmc, Ectd, Life Sciences, Cro Management, U.s. Food and Drug Administration, Electronic Common Technical Document, Standard Operating Procedure, Good Laboratory Practice, Corrective and Preventive Action, Good Clinical Practice

Civil Rights and Social Action
Education
Environment
Animal Welfare
Health

Rac
Raps Usa

Monsey, NY

Pharmaceuticals

Hospira Nov 2011 to 2000
Quintiles, Regulatory/Compliance Consultant Merck - Kenilworth, NJ 2011 to 2011
Global Regulatory Affairs Consultant Pharmalink and Maruho Research 2009 to 2009 Major Client, Stiefel Research Institute 2005 to 2008
Reviewer of Module Regulatory Affairs - Farmingdale, NY Apr 2004 to Sep 2005
Director Tunnell Consulting - King of Prussia, PA Oct 2002 to Apr 2004
Managing Consultant Osiris Therapeutics, Inc - Baltimore, MD Mar 2001 to Oct 2002
Director, Regulatory Affairs and Quality Assurance BioSpecifics Technologies Corp - Lynbrook, NY Oct 1992 to Mar 2001
Director, Regulatory Affairs and Quality Assurance Caraco Pharmaceutical Laboratories, Ltd - Detroit, MI Mar 1991 to Sep 1992
Director Clinical Research Associates - New York, NY May 1990 to Mar 1991
Consultant and Technical Coordinator Melville Biologics - Melville, NY May 1989 to May 1990
Quality Control Manager NMC Laboratories, Inc - New York, NY Aug 1983 to May 1989
Laboratory Director Forest Laboratories, Inc - Inwood, NY Mar 1981 to Jul 1983
Quality Control Director

University of Tennessee - Knoxville, TN 1980
PhD in Food Technology and Science University of Tennessee - Knoxville, TN 1977
MS in Food Technology and Science Arnold and Mary Schwartz College of Pharmacy
Pharmaceutical Sciences Long Island University