Regulatory Affairs Professional Certification

Regulatory affairs professionals must have a solid understanding of regulations in the U.S. and abroad.
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Before a woman can use a drug like birth control or hormone-replacement therapy, a regulatory affairs professional toils behind the scenes to help pharmaceutical companies gain FDA approval. Regulatory affairs professionals work independently as consultants or in-house for companies and help sort through regulations from other countries, as well as the United States. While not necessary for employment, certification looks great on a regulatory affairs professional’s resume and gives her legitimacy in the field.

Choose Your Provider

Certifications come from a variety of sources, including industry associations like the Regulatory Affairs Professional Society, which offers the Regulatory Affairs Certification, one of the main credentials for regulatory affairs professionals. Other professional associations, such as the Center for Professional Innovation and Education, also provide credentials for regulatory affairs professionals. Several specialty designations also exist from groups like the American Association for Clinical Chemistry.

Meet the Requirements

Each provider sets its own requirements for earning certification. The usual requirements include paying application, course and/or exam fees. Many providers also ask for a specific educational background and a certain number of years of experience. RAPS, for example, mandates that candidates hold a bachelor’s degree and have at least three years of professional regulatory experience.

Courses and Exams

Each provider assesses the candidates to be sure they are up to par to receive certification. Assessment comes in several forms, including mandatory courses, certification exams or a combination of the two. The CfPIE program, for example, involves the candidate choosing three mandatory core courses and one elective course, each of which include an exam at the end that candidates must pass to earn the designation. RAC, on the other hand, requires only a certification exam to assess candidates, with no courses. Topics typically covered in courses and exams include FDA regulations, regulations for other continents, medical devices, adverse drug events, manufacturing practices, medical devices and quality control.

Maintenance and Upkeep

Once a candidate earns certification, she must take the steps to keep and maintain certification. The recertification process typically includes renewing every few years, generally one to three years, and submitting a renewal application and fee. Additionally, most providers require certification holders to earn a certain number of continuing education credit hours to maintain the designation. For example, RAPS requires renewal every three years and earning 36 CE credit hours during the three-year renewal period. CE credits come from a variety of sources, such as courses, online classes, educational events, speaking engagements, publishing industry articles and participating in industry-related organizational events.

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