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The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
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Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
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With contributions from more than 30 authors from seven countries, the new edition incorporates a global overview of the field and is designed to help you get the most out of your regulatory intelligence endeavors.
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Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Posted 25 February 2014 | By Alexander Gaffney, RAC,
US pharmaceutical regulators in the US Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) are looking to hire a new executive to head up its Office of Regulatory Policy (ORP).
The announcement, made in a 24 February 2014 posting on the USA Jobs website, calls for someone with legal training and at least five years of "specialized experience providing legal advice" on the development, interpretation or implementation of regulations, laws and policies.
The office is currently led by Acting Director Nancy Hayes and Deputy Director Carol Bennett, according to FDA's website.
CDER's listing notes that ORP is highly influential in crafting policies impacting a wide range of areas, including drug safety, clinical trials, new drug applications, over-the-counter medications, drug quality, good manufacturing practices, drug promotion and marketing, and more.
Applicants have until 24 March 2014 to submit their resumes for the position.
ORP Director Posting
Tags: Office of Regulatory Policy, ORP, Latest News
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