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Regulatory Affairs

  • Ronald A. Guido
  • Alan V. McEmber
Part of the Series in Biomedical Engineering book series (BIOMENG)

When exploring alternative career paths for life scientists, discussions of the regulatory affairs role are met with what may be best described as uninformed interest. After lecturing on topics in regulatory affairs at the graduate level, hallway discussions eventually gravitate towards the type of questions typically heard at a job fair. Highly trained and scientifically astute students approach us looking for insight into pharmaceutical career options. Peppered among the queries of “how do I break in” and “do you have a business card,” most will say they often heard that regulatory affairs is a great career – but are unsure what it is. We will address these and other related issues in this brief chapter.

Describing careers in regulatory affairs should be an easy task for someone with years of experience in the field – right? Not exactly. The constant evolution and differences in the practice of regulatory affairs make it difficult to succinctly describe the field. Moreover,...

Keywords

Drug Development Process Regulator Query Regulatory Affair Clinical Development Program Biotechnology Product 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

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Copyright information

© Springer Science+Business Media, LLC 2008

Authors and Affiliations

  • Ronald A. Guido
    • 1
  • Alan V. McEmber
    • 1
  1. 1.Global Research and DevelopmentPfizer, Inc.USA

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