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RAPS' Latest | 10 February 2015 | By Zachary Brousseau
If you are considering taking one of the four Regulatory Affairs Certification (RAC) exams, one of the first things you need to do is determine whether you meet the exam eligibility requirements. The criteria are not complicated, but since they were changed—the updated criteria went into effect beginning with the autumn 2014 exam period—there may be some lingering confusion over the exact requirements.
To be eligible to take the RAC exam, you must have at least a bachelor’s or first university degree, and some regulatory or regulatory-related experience. How much experience you need depends on your highest earned degree. You are qualified to take the exam if you have:
Prior to the change, RAC exam takers needed either a bachelor’s degree or three years of experience. In 2013, the Regulatory Affairs Certification Board (RACB), which oversees the exams, determined that requirement was not rigorous enough. With the responsibilities and the advanced skills regulatory professionals need to have today, the RACB felt it appropriate to require at least a bachelor’s degree along with some real-world experience.
Although the eligibility criteria was changed in 2014, the RAC exams always have been intended for professionals with 3–5 years in the regulatory field. The exams are experience-based, requiring not only knowledge of the regulations, but also how to apply them in practice.
If you have been in the regulatory profession for more than three years, you are likely a good candidate for the RAC, but don’t be discouraged if “regulatory affairs” is not in your job title. Regulatory-related experience counts too. Related fields include quality assurance, quality control, clinical research and healthcare product project management.
It is important to remember that being eligible is not the same as being ready for the exam. So, if you are eligible, you should also take some time to assess whether the RAC is right for you, learn about the four different RAC credentials and evaluate your exam readiness.
Review the content outline for the exam that interests you. All four outlines are linked from RAPS’ RAC preparation page and are included as appendices to the RAC Candidate Guide. Also, RAPS has created helpful self-assessment tools for the RAC (US) and RAC (Global). An assessment tool for the RAC (EU) also is in the works. See the RAC Candidate Guide for more about the application process, scheduling, exam logistics, etc.
Tags: Affairs, Certification, RAC, Regulatory