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Best Practice Database
Quality, Compliance and Regulatory » Regulatory Affairs
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The pharmaceutical industry uses Regulatory Affairs as its main communicator with the FDA. The success of a Regulatory Affairs group starts with hiring the right people. That’s not an easy task since a Regulatory Affairs professional requires an array of capabilities, from an understanding of basic science to possession of nimble negotiation skills. This study examines what is the most desirable skill set for a new Regulatory Affairs employee and the benefits/drawbacks of hiring former FDA officials. Regulatory leaders can use the insights from this research to compare their group’s skill sets and to consider whether to hire former FDAers.