Work:
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
Education:
University of Tennessee, Knoxville 1975 - 1980
Master of Science, Doctorates, Masters, Doctor of Philosophy, Philosophy, Chemistry, Food Science
Skills:
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
Interests:
Civil Rights and Social Action
Education
Environment
Animal Welfare
Health