Is Regulatory Affairs Certification Right for You?

Posted 06 February 2017 By Zachary Brousseau


If you are a regulatory professional considering pursuing Regulatory Affairs Certification (RAC), you are not alone. RAC is a recurring topic of discussion in online forums where regulatory professionals and those looking to get into the profession ask questions and exchange ideas, such as the Regulatory Open Forum on RAPS' Regulatory Exchange, the RAPS LinkedIn group discussion or Elsmar Cove.

You may be wondering what the return on investment of getting the RAC will be, or whether you are ready to take one of the challenging RAC exams? The answers to these questions depends largely on you.

Variables to consider include 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 your 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 if you are in a position to leverage it. Are you trying to break into regulatory from another field? In that instance, you should take a hard 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). 

Reason No. 1 to Get the RAC: Credibility

The RAC occupies a unique position as the only post-academic professional credential specifically for regulatory. “Short of an academic degree, it is the only public symbol of achievement within the regulatory profession,” says Ray Huml, MS, DVM, RAC, vice president, global strategic drug development and head of global biosimilars strategic planning for Quintiles. It demonstrates that you have a solid foundation of regulatory knowledge, as well as analysis and critical thinking skills. It gives the RAC holder additional credibility among those who know what the credential signifies.

Having the RAC as evidence of your regulatory knowledge can enhance your value to your employer or inspire greater confidence among your clients if you are a consultant. A few years ago, RAPS asked attendees at its Regulatory Convergence about the value of the RAC. Mark Gordon, RAC, FRAPS, former RAPS chair and current divisional vice president for regulatory affairs at Abbott, touched on the value from a manager’s perspective, saying he encourages his entire staff to go for the RAC. “For beginning professionals up through managers, I think it’s outstanding,” said Gordon. Addressing its value in attracting clients, Betty Ann Cory, RAC, president, RegXia, said, “The RAC has always provided a level of credibility, I think, to my consulting business…It does give you an identity with new customers. It’s something that they look at first.”

Reason No. 2 to Get the RAC: Better Pay

Another potential benefit of the RAC is higher pay. “If I am hiring, I would tend to pay a person who has an RAC more than someone who does not. If the company is fully aware and understands regulatory, the RAC should mean better compensation, but it is very company-dependent,” said Peter Takes, PhD, RAC, FRAPS, principal, Regulatory Intelligence Associates LLC.

Compensation data show that many employers are indeed willing to pay more for those who have the RAC. According to RAPS’ most recent Scope of Practice and Compensation Report, respondents based in North America who have the credential make 11% more in base and total compensation than their peers without it. And the salary boost is even more pronounced at early career levels, with associates and specialists making 24.4% and 14.3% higher base salaries, respectively.

Reason No. 3 to Get the RAC: 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 usually trumps any credential, an RAC can give your prospects a boost, in some cases compensating for less experience.

“As an executive recruiter that specializes in placing regulatory professionals, I do see that hands-on experience stands out more than certifications,” says Mark Carlson, a certified placement consultant and senior search consultant for Prestige Scientific. “However, there are always caveats. I have many clients that will accept less hands-on experience with advanced degrees and also with RACs. It’s going to depend on each employer.”

Considerations for Professionals Outside the US

US-based RAC holders have an advantage when it comes to awareness of the credential—at least for now. According to the Scope of Practice Report, North America—and particularly the US—has the highest number of RAC-credentialed professionals, and recognition of the credential seems to be highest in US as well. But recognition in Asia, Europe and other regions is growing as are the number of RAC holders.

“It takes a bit more explaining in Europe to make people—like your boss—understand what a great accomplishment it is to pass the RAC exam,” says Beate Schmidt MSc, MDRA, RAC, RAPS European liaison. “But even if people aren't familiar with the program per se, holding these unique professional credentials demonstrates a great level of knowledge and expertise, and it certainly speaks to your commitment to your job and continued professional learning.”

According to the Scope of Practice Report, RAC holders in Europe reported an average of 21.6% more than non-credentialed professionals. While the sample size is smaller than US-based respondents, it could indicate the credential may be gaining additional awareness and prestige in Europe. 

Reasons No. 4 and 5 to Get the RAC: Expand Knowledge, Stay Current

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 force you to learn new areas of regulation as well as reinforce your established expertise. “I think the exam is worth the investment, and allows you to expand your knowledge by looking outside your product scope,” says Darin Oppenheimerr, director, regulatory CMC and combination products, Merck.

“I now have a better understanding of the aspects of the regulations I am less involved with, such as labeling, medical devices, clinical trials, etc.,” says Elodie Martin, regulatory project leader with Sanofi. “This helps me collaborate better with other regulatory professionals in my company.”

To maintain the credential, RAC holders must earn 36 recertification credits every three years by participating in continuing education and other professional activities. This provision affords its own benefit, say many who have the RAC. “The continuing education requirement helps ensure that we take the time to step back from our daily activities and stay current with what is happening in the regulatory landscape,” says Paul Swift, director of regulatory affairs, Alcon.

Assess Your Experience and Readiness

Are you eligible and ready to take the RAC exam? RAC eligibility requirements changed beginning with the autumn 2014 exam cycle, so 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 any of 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 using study checklists, all of which are linked from RAPS’ RAC preparation page on You can find out more about the application process, scheduling, exam logistics and more in the RAC Candidate Guide.

Other Options

If you have completed your assessment and determined that what you want or need is additional regulatory training and education rather than certification, there are a number of options. One is RAPS’ Regulatory Affairs Certificate Program, which is sometimes confused with RAC, but is very different from certification.

The certificate program is a series of online courses designed to give you knowledge in specific healthcare product areas—pharmaceuticals, medical devices or a combined certificate in both. Once earned, you receive a certificate that does not have ongoing maintenance or renewal requirements.

There also are a number of certificate programs available from other institutions, as well as master’s degree programs. RAPS maintains a list of such programs for easy reference.

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. Since RAC is valued by employers, many will provide funding for exam fees or study materials. Study groups can be found through local RAPS chapters or may organize informally through message boards or social media. Some larger companies have internal RAC study groups.

If you are considering trying for your RAC or just thinking about it, you should learn as much as you can—about the exam, the resulting credential and its requirements. Talk to everyone you can who has the RAC or knowledge of it. While gaining experience is the best investment you can make in your regulatory career, the RAC may help you stand out a bit more. 


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