Regulatory Competency Framework

2021 Competency Framework

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Regulatory Competency Framework and GuideThe 2021 Regulatory Competency Framework from the Regulatory Affairs Professionals Society (RAPS) describes the essential elements of what is required of regulatory professionals at four key career and professional levels.

The 2021 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—the framework is designed to be relevant to all regulatory professionals. 

“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

New Framework-Based Tools Are Here!

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These two members-only tools are based on the 2021 Framework and are designed to systematically evaluate the performance of regulatory professionals and to create customized individual development plans.

Regulatory Competency Framework Addendum The 2022 Regulatory Competency Framework Addendum provides performance criteria for the 2021 Framework. Performance criteria can be adapted for use by professionals and human resource departments for the development and performance management of regulatory affairs professionals at all levels.


Performance Assessment ToolThe RAPS Performance Assessment Tool is an excel-based template that complements the Framework. This tool was designed to help evaluate gaps in individual performance and to identify actionable areas for development. This tool can be used by managers or as a self-assessment.