Vice President Regulatory Affairs @ (June 2021 - January 2023)
Head Of Regulatory Affairs, Acting @ (August 2020 - May 2021)
Vice President, Scientific and Regulatory Affairs @ (July 2016 - March 2017)
Principal Consultant @ (July 2015 - July 2016)
Vice President Regulatory Affairs @ (October 2010 - March 2012)
Senior Director, Regulatory Affairs @ (August 2009 - October 2010)
Executive Director Regulatory Affairs and Quality Assurance @ (March 2008 - August 2009)
Director, Regulatory Affairs @ (July 2007 - March 2008)
Director, Regulatory Affairs @ (August 2005 - July 2007)
Director, Regulatory Affairs @ (April 2005 - August 2005)
Associate Director, Regulatory Affairs @ (October 1995 - May 2005)
Group Leader @ (September 1984 - October 1995)
James Medley Education
Louisiana State University
PhD (Chemistry)
1976-1981
Louisiana State University
Doctor of Philosophy (Ph.D.) (Inorganic Chemistry)
1976-1981
Wofford College
Bachelor’s Degree (Chemistry)
1972-1976
James Medley Skills
Clinical Development
IND
NDA
Clinical Trials
Biotechnology
eCTD
Technology Transfer
Regulatory Submissions
GMP
CMC
Sop
Biopharmaceuticals
Pharmacovigilance
Regulatory Requirements
GLP
Pharmaceutics
HPLC
Drug Delivery
Strategy
Pharmaceutical Industry
FDA
Regulatory Affairs
Drug Development
U.S. Food and Drug Administration (FDA)
James Medley Summary
James Medley, based in Fort Valley, VA, US, is currently a Principal at Massanutten Pharmaceutical Services, LLC. James Medley brings experience from previous roles at Cencora- formerly PharmaLex Development Services, LLC, Pharmaceutical Advisors LLC, Althera and Innocoll. James Medley holds a 1976 - 1981 PhD in Chemistry @ Louisiana State University. With a robust skill set that includes Clinical Development, IND, NDA, Clinical Trials, Biotechnology and more. James Medley has 1 emails and 1 mobile phone numbers on RocketReach.
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