RAPS releases framework addendum and assessment tool for regulatory professionals

Today, the Regulatory Affairs Professionals Society (RAPS) released its Regulatory Competency Framework Addendum: Performance Criteria, which is an extension of the 2021 Regulatory Competency Framework report. A new performance assessment tool accompanies the framework.

“Specifically, the addendum provides performance criteria as outlined in the most recent report,” explained Lindsey Summers, MBA, who served as vice chair of the addendum committee. “Regulatory affairs professionals at all levels—and those involved in supporting the ever-changing future of talent in the global workforce—can adapt performance criterion examples to aid with hiring, developing, and performance management.”

The new performance assessment tool aligns with the framework, enabling users to systematically assess performance and provide an actionable plan for closing gaps in skills and regulatory knowledge.

“This tool will aid in measuring regulatory affairs performance and spot areas where additional guidance, development, training and/or education may be useful,” said Thomas Hutchinson, MS, RAC, FRAPS, who served as chair of the committee that oversaw the framework’s development.

The underlying Regulatory Competency Framework 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.

The framework describes the essential elements of what is required of regulatory professionals at four key career and professional levels. The framework is relevant to regulatory professionals across healthcare-product sectors, including pharmaceuticals, medical devices and biotech.

In addition to being applicable to different product sectors, the framework can be useful to professionals working not only in regulated industry, but also to those in government, research, clinical and other settings. It is relevant to all regulatory systems and geographic regions.

The framework is the result of years of ongoing research and development with the guidance of RAPS’ members and volunteer experts. The current iteration builds upon preceding versions and includes significant updates and improvements to the 2016 edition.