Compliance Insight, Inc.
Associate Director, Regulatory Compliance
Aprecia Pharmaceuticals Feb 2016 - Sep 2016
Manager, Regulatory Affairs
Mimedx May 2014 - Jan 2016
Manager, Regulatory Affairs
Immucor, Inc. Feb 2012 - May 2014
Principal Regulatory Affairs Specialist
Arbor Pharmaceuticals Feb 2011 - Feb 2012
Senior Manager, Quality and Regulatory Affairs
Education:
Kentucky State University 1989 - 1994
Bachelors, Bachelor of Science, Biology
Skills:
Regulatory Affairs Fda Pharmaceutical Industry Regulatory Submissions Quality Assurance Medical Devices Gmp Biotechnology Change Control Regulatory Requirements Ind Pharmaceutics Clinical Research U.s. Food and Drug Administration Cmc Life Sciences Glp Regulations Standard Operating Procedure Electronic Submissions Nda Ectd Good Laboratory Practice Food Dmf Cosmetics Cross Functional Team Leadership Training Leadership Gxp Consulting Regulatory Compliance
May 2014 to 2000 Manager, Regulatory AffairsImmucor Inc Norcross, GA Feb 2012 to May 2014 Principal Regulatory Affairs SpecialistArbor Pharmaceuticals Inc Atlanta, GA Feb 2011 to Feb 2012 Sr. Manager, Quality and Regulatory AffairsShionogi Pharma, Inc Atlanta, GA Nov 2007 to Jan 2011 Manager, Regulatory AffairsXanodyne Pharmaceuticals, Inc Newport, KY Mar 2006 to Oct 2007 Manager, Regulatory AffairsPharmacia Hepar, Inc
Jul 2002 to Mar 2005 Regulatory Affairs ManagerPharmacia Hepar, Inc
Aug 2001 to Jul 2002 Acting Regulatory Affairs ManagerPharmacia Hepar, Inc
Jun 2001 to Aug 2001 Assistant Regulatory Affairs ManagerEurand America, Inc Vandalia, OH Mar 2001 to Jun 2001 Quality Assurance AuditorPhoenix International Life Sciences, Inc Cincinnati, OH Mar 1999 to Sep 2000 Senior Quality Assurance Auditor/Regulatory Compliance SpecialistFDA Cincinnati, OH Jun 1994 to Mar 1999 Investigator (Consumer Safety Officer)
Education:
Kentucky State University May 1994 Bachelor of Science in Biological Health Science