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Global Regulatory Affairs Fellowship UNC/GlaxoSmithKline

Company: Eshelman School of Pharmacy, University of North C
Location: Chapel Hill
Posted on: October 30, 2018

Job Description:

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 .

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

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