Regulatory Competency Framework

Regulatory Competency Framework and GuideThe 2021 Regulatory Competency Framework is a one-of-a-kind tool to help you plan professional development and training for yourself or your regulatory staff. Whether working in the US, Europe, Asia—or anywhere around the world—with medical devices, pharmaceuticals, biologics or other healthcare products, the framework is designed to be relevant to all regulatory professionals. The competencies it describes are applicable to professionals working in all product sectors and regulatory systems. It is a single framework made to be customized and adapted in innumerable ways.

Regulatory Competency Framework Sample“The Regulatory Competency Framework is designed to be highly flexible, and may be customized, built upon and applied to many different career paths and workplaces. It can be used by regulatory professionals to identify the competencies they need to advance their careers, by companies to design training and professional development resources for their regulatory staffs, or by academics to plan and improve curriculum.” – Thomas Hutchinson, MS, RAC, FRAPS, RCF Task Force Chair

The framework describes in simple, straightforward statements, the essential elements of what is required of regulatory professionals at four key career and professional levels.

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