In 2016, RAPS released its Regulatory Competency Framework, a tool to help professionals and organizations develop regulatory training, and plan career and professional development. A few organizations began using the Framework immediately. We spoke to former RAPS Chair Sue James, who is vice president of global regulatory affairs at GlaxoSmithKline (GSK) Consumer Healthcare about the Framework and how it has been used at GSK.
Regulatory Focus: What do you see as the primary value of RAPS’ Regulatory Competency Framework? And who is likely to benefit most from using the Framework?
Sue James: The whole thing is just enormously valuable. I think there are three groups of people who benefit from it—first of all the professional. It lays out an expectation of what they need to master at each level of their careers and provides transparency. It’s enormously helpful for department heads. It sort of normalizes the profession, laying out what the competencies are at each level, keeping in mind that the skillsets might be different based on the work in specific areas like pharma, biologics or whatever. The same benefits are true for the employer and recruiters, offering a yardstick or benchmark against which expectations are set.
RF: Can you talk a little bit about how the Framework is being used at GSK?
SJ: Within GSK, we have an HR site called “my winning career,” and within that there are profiles of expectations and competencies at each level for everyone within GSK. When we were putting together those profiles recently, and getting ready to launch the website, I leveraged the RAPS Regulatory Competency Framework to ensure alignment between GSK’s competencies for regulatory staff and those identified by RAPS. I drew on it very heavily but had to customize it For GSK. It was extremely helpful.
RF: Do you think the Framework will become a recognized standard for the regulatory profession?
SJ: I think it should become a recognized standard. For that to happen, I think we need to use it. So for example, we could make reference to the professional level when posting jobs.
I find that often there is someone in one company who is at a manager level who might be a director at another company. A regulatory professional who is at one level in GSK pharma should be at the same level at GSK vaccines, and likewise their skills should be recognized in a similar way at another company. If someone is a manager, and let’s say that’s equivalent to a level two, it should be possible to expect their competencies are the same from company to company.
You would expect a group of regulatory people to have job and professional expectations well documented. I think they’ve done a phenomenal job putting together the framework.
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