The UNC Eshelman School of Pharmacy, in cooperation with GlaxoSmithKline, sponsors two-year fellowships in global regulatory affairs.
Fellowship objectives are to provide training and experience in critical aspects of regulatory affairs, including:
Regulations, guidelines and policies in the United States and Europe;
Principles and applications of pharmaceutical product development and evaluation, research design and methodology;
Requirements and mechanics of Investigational New Drug filings and maintenance and New Drug Application submissions;
Regulatory strategy development, use and interpretation of regulations and guidelines, and interactions with regulatory agencies;
Principles of regulatory agency review processes in the United States, with exposure to the processes in Europe and emerging markets where possible;
Critical assessment of drug packages in the pharmaceutical and clinical settings;
Strategic interactions with and submissions to regulatory agencies;
Drug advertising and labeling critical assessment; and
Regulatory intelligence and policy research.
The fellowship is designed to enable each fellow to train at the University of North Carolina in Chapel Hill under the direction of UNC faculty, and in the Global Regulatory Affairs Department at GlaxoSmithKline in the Research Triangle Park, North Carolina, and/or in GlaxoSmithKline facilities in Philadelphia. In addition, there is the potential to gain experience in agency aspects of regulatory and regulatory science (ex. PhRMA, Food and Drug Administration). For more information, visit http://pharmacy.unc.edu/programs/fellowships.
Preferred qualifications include a PharmD, PhD, or MD. An advanced degree must be conferred by the time of appointment.
About Eshelman School of Pharmacy, University of North Carolina at Chapel Hill
The UNC Eshelman School of Pharmacy is a nationally recognized leader in progressive pharmaceutical care practice, education, and research. Throughout its history, the School has built a reputation for cutting edge research, rigorous training programs, and outstanding faculty, staff, and students. The School provides students with a wide range of opportunities. A world-class university, a model Ar...ea Health Education Center (AHEC) system, an award-winning hospital system, and an international center for pharmaceutical research and development, Research Triangle Park, create one of the most dynamic centers of learning in the nation.
The School is one of five health affairs schools on the campus of the University of North Carolina at Chapel Hill and benefits from close collaborations with many on-campus research programs, including the Carolina Center for Genome Sciences, the Lineberger Comprehensive Cancer Center, the Center for Infectious Diseases, and the McAllister Heart Institute.
The School is the number one ranked pharmacy program based on the U.S. News & World Report ranking and is one of the leaders among schools of pharmacy in federal research funding. The School added 75,000 square feet of state-of-the-art research space in 2009 with the Genetic Medicine Building and added another 75,000 square feet in Marsico Hall in 2014.