The UNC Eshelman School of Pharmacy, in cooperation with GlaxoSmithKline, sponsors two-year fellowships in global regulatory affairs.
Two regulatory affairs fellows will be recruited. One fellow will support the Oncology Therapy Area, while a second fellow will support Chemistry Manufacturing and Controls (CMC) for Biotherapeutics.
NOTE: When requesting an interview, specify which fellowship you are applying for in your Letter of Interest. Be sure to include your Letter of Interest along with your CV.
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 sponsors intend for fellows to train and gain interdisciplinary team experience within the GlaxoSmithKline Research & Development facility located in Upper Providence, Pennsylvania (about a 45-minute drive from downtown Philadelphia) for the duration of the fellowship. For more information, visit https://pharmacy.unc.edu/academics/fellowships/gsk-gra/.
Preferred qualifications include a PharmD, PhD, or MD. An advanced degree must be conferred by the time of appointment.
Application requirements: CV, letter of interest, unofficial transcripts, and three professional letters of recommendation.
Start date: July 1, 2020
Additional Salary Information: Compensation includes a standard UNC benefits package, health insurance, and support for professional travel and career development.
About Eshelman School of Pharmacy, University of North Carolina at Chapel Hill
At the UNC Eshelman School of Pharmacy, everything we do begins and ends with a patient in mind. We are preparing the next generation of scientists, clinicians and practitioners to discover solutions to the world’s most challenging health care issues. Throughout our history, the School has built a reputation for cutting edge research, rigorous training programs, and outstanding faculty, staff, and students. A world-class university, a model Area Health Education Center (AHEC) system, an award-winning hospital system, and an international center for pharmaceutical research and development, and close proximity to the Research Triangle Park, creates 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 research funding.