Industry Sponsored Global Regulatory Affairs Fellowship UNC/GlaxoSmithKline

Company: Eshelman School of Pharmacy, University of North C
Location: Chapel Hill
Posted on: January 14, 2021

Job Description:

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/ .

Keywords: Eshelman School of Pharmacy, University of North C, Chapel Hill , Industry Sponsored Global Regulatory Affairs Fellowship UNC/GlaxoSmithKline, Other , Chapel Hill, North Carolina