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Is Regulatory Affairs Certification right for you?

Posted 04 February 2021 | By Zachary Brousseau 

Is Regulatory Affairs Certification right for you?

If you are a considering pursuing Regulatory Affairs Certification (RAC), you may be wondering what the return on investment will be, or whether you are ready to take one of the challenging RAC exams? The answers to these questions depend largely on you.

Before you decide, you should consider things like the amount of regulatory experience you have, potential additional credibility to be gained, the level of support you have from your employer and how much time you can devote to studying. So while there is no one-size-fits-all answer to the question ‘Is the RAC right for me?,’ there are some important factors to take into account.

First, you should know why you want to get the RAC, and what you hope to gain from having it. Do you want increased credibility, a higher salary or a new job? RAC can be a significant contributing factor to all these goals.

Are you trying to break into regulatory from another field? In that instance, you should take a good look at your background and experience to determine if RAC is a good fit. The exams are experience-based and intended for professionals with 3–5 years in the regulatory field. If you are new to regulatory or short on experience, there may be better ways to invest in your career now, while you work toward taking the RAC exam once you gain additional experience (see Other Options below).

Reasons to Get the RAC


The RAC is the leading credential for regulatory professionals in the healthcare product sector. It demonstrates that you have a solid foundation of regulatory knowledge, as well as analytical and critical thinking skills. Having the RAC as evidence of your regulatory know-how can enhance your value to your employer or inspire greater confidence among your clients if you are a consultant.

Better Pay

Another potential benefit of the RAC is higher pay. According to RAPS’ 2020 Global Compensation & Scope of Practice Report, US-based respondents with the credential, on average, earn 9% more than their peers without it. While it depends on the employer, hiring managers familiar with the RAC may be willing to pay an RAC holder more than a comparable professional without the credential.

Better Job Prospects

As an outward indication of regulatory knowledge that has clear value to employers and clients, RAC can help credentialed professionals stand out to potential employers. While experience generally trumps any credential, an RAC can give your prospects a boost, in some cases compensating for less experience.

Expand Knowledge

Although it may not be the primary reason driving you to get the RAC, the process of studying for your exam can be a benefit itself. Preparing for the exam will require you to learn new areas of regulation as well as reinforce your established expertise.

Stay Current

To maintain the credential, RAC holders must recertify every three years by participating in continuing education and other professional activities. This provision affords its own benefit, say many who have the credential. The continuing education requirement helps ensure RAC holders take the time to stay current with new regulations and developments.

Assess Your Experience and Readiness

Are you eligible and ready to take the RAC exam? First, check to be sure you meet the experience and education requirements. RAC is not intended as vehicle to help you get your first regulatory job. Those with no regulatory or regulatory-related experience at all are ineligible to take the RAC exams. It is important to keep in mind that the RAC exams are experience-based and designed for professionals with 3–5 years of regulatory experience. The exams are rigorous; the pass rate is generally in the 40–50% range.

Learn what is covered on each exam by reviewing the content outlines and assess your own areas of strength and weakness. RAPS’ free study checklists for the RAC Devices and RAC Drugs exams may be useful. Personalize your study plan. To prepare for the exam, you should focus on developing your knowledge in areas where you have limited experience, as well as expanding your knowledge in your areas of expertise. RAPS offers RAC exam prep resources that can help.

You can find out more about the application process, scheduling, exam logistics and more in the RAC Candidate Guides. Note that RAPS recently expanded its pilot program offering the opportunity to take the RAC exam online from home or another remote location.

Gather Support

Getting support for your RAC efforts can be extremely helpful, and if you are on the fence about sitting for one of the exams, a supportive employer or the opportunity to join a local study group may just push you to go for it. Find out if your employer will provide funding for exam fees or study materials. Study groups can be found through local RAPS chapters or may organize informally.

If you are ready to pursue the RAC or just thinking about it, learn as much as you can—about the exam, the resulting credential and its requirements. Talk to everyone you can who has the RAC.

Other Options

What if you have completed your assessment and determined that what you want, or need is additional regulatory training and education rather than certification? A popular option is one of RAPS’ Regulatory Affairs Certificate Programs, which are sometimes confused with RAC. You can find out more about the differences here. There also are certificate and master’s degree programs offered by academic institutions.


© 2021 Regulatory Affairs Professionals Society.

Tags: RAC

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