What Is The Regulatory Affairs Certification (RAC) and Why Do I Need It?


The Regulatory Affairs Certification (RAC) is the only post-academic credential for regulatory professionals in the healthcare product industry. Simply put, it is the gold stamp of approval that sets regulatory professionals apart as experts.

Offered through the Regulatory Affairs Professional Society (RAPS), the RAC provides an official mark of distinction for those working in regulatory affairs. It is geared towards those working in regulatory agencies, consultancies, and corporations operating within the purview of healthcare product development, distribution, and regulation. The RAC distinguishes an individual as being committed to excellence, professional development, and career advancement.

Read on to learn why the RAC is important, how it works, and what it takes to get it.

Why Do I Need the RAC?

As global demand for regulatory professionals increases, those with the RAC put themselves at the top of the list for employment opportunities and into prime consideration for leadership responsibilities. Approximately 7,000 people have been certified through the RAC; they are rising leaders in the regulatory arena. In 2016, RAC holders in North America reported earning 11 percent more than their non-credentialed peers.

Furthermore, the RAC requires not only industry-specific knowledge, but also portable skill sets in critical thinking, adaptive reasoning, and collaboration. A RAC can in effect boost the prestige of one’s resume, regardless of the sector or job role to which one applies.

How to Earn the RAC

To earn the RAC, one must pass a computer-based test designed for one of four geographic regions: the United States, Canada, the European Union, or Global. The exams are created by surveying veteran industry professionals on their scope of practice, as well as specific roles and responsibilities. Each test consists of 100 multiple choice questions that must be answered in a two hour period at a sanctioned testing center. The questions fall into three general categories: recall, application, and analysis. The topics addressed include biologics and biotechnology, in vitro devices, medical devices, pharmaceuticals, and regulatory functions across the product lifecycle.

Each exam is designed specifically for its geographical jurisdiction, and therefore those aspiring to earn an RAC should thoroughly acquaint themselves with local regulations according to their geographic region.

How Can I Qualify for the RAC Exam?

There are a few boxes to tick before taking the test. To be eligible to take the RAC exam, a candidate must be one of the following:

  • Bachelor’s degree holder with three years of regulatory experience
  • Master’s degree holder with two years of regulatory experience
  • Doctoral degree holder with one year of regulatory experience

Regulatory experience could include quality assurance, quality control, or clinical research related to the approval of healthcare products.

Since the tests are developed through extensive surveying and academic studies, the results can’t be offered up for free. Taking the test costs $465 for RAPS members and $585 for non-members.

Aspiring RAC candidates also must consider timing. Application deadlines are March 1 for the first testing window and September 1 for the second testing window. The first testing window is April to May and the second is October through November. Applications can be submitted through the RAC page.

Then, to pass the test, regulatory professionals have to schedule enough time to review the content of the exam, assess their depth of experience, and implement a study plan.

Tests are scored from 0 to 99, with 75 being the cutoff point for passing. The values are not necessarily correlated to the number of questions answered correctly or the percentage of questions answered correctly, but instead through a weighted statistical process to account for variations in question difficulty over the years. Therefore, most RAC exam-takers are forced to focus on doing the best they can and cross their fingers until the test is graded.

Those behind the RAC want experienced and intelligent professionals to succeed. RAPS offers a wealth of resources to help applicants prepare and review the exam. They also offer test-takers a prep toolbox for their geographic region for an additional fee, which includes:

  • An e-book of the US Regulatory Acronyms & Definitions
  • An RAC practice exam
  • An interactive study checklist
  • An exam content cutline
  • More than 25 hours of in-depth e-learning review material, including content from the Fundamentals of U.S. Regulatory Affairs
  • Hands-on activities to help improve test-taking skills

Even if one does not pass on their first attempt, they are eligible to retake the exam as soon as the next testing window opens.

How to Renew the RAC

Obtaining the RAC does not end with certification. Every three years, RAC holders are required to renew their certification through the completion of 36 RAC credits. Credits can be earned in several ways: continuing education, public speaking, professional writing, and involvement with professional organizations. This renewal process ensures that only current experts hold the badge of RAC, thus maintaining the value of each individual’s certification.

Earning the RAC takes time, money, and effort, but it can result in professional distinguishment and career advancement. The monetary costs can be recouped through the boost in salary that comes with certification. The time spent studying for the test and earning renewal credits can serve to boost one’s professional network and industry expertise.