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About the RAC

The Regulatory Affairs Certification (RAC) is the only globally recognized professional credential for those involved with the regulation of healthcare products. The RAC exam tests your regulatory knowledge, as well as your critical thinking ability, in four areas of regulatory practice.

RAC professionals are today’s leaders—setting the bar high for industry knowledge, dynamic critical thinking ability and a commitment to ongoing education.

A RAC is obtained by passing a rigorous exam and maintained by acquiring continuing education credits within a three-year cycle.

Four certifications are available:

  • RAC (US): Knowledge of US regulations
  • RAC (EU): Knowledge of European Union regulations
  • RAC (CAN): Knowledge of Canadian regulations
  • RAC (Global): Knowledge and critical thinking skills related to the general scope of practice of regulatory professionals throughout the product lifecycle, with reference to global standards from ICH, GHTF, WHO and ISO.

Our online RAC self-assessment survey will help you evaluate your areas of expertise and growth to assist in choosing the right RAC for you, and our practice and simulation exams will help you take the next steps in evaluating your readiness in taking the RAC exam.

Regulatory Professionals with RAC Certification

For a list of current RAC holders, please view the Regulatory Professionals with RAC Certification report

RAC holders earn 10 percent higher salaries than those without, on average (based on 2011 salary data from professionals based in North America) .

Certification Vs. Certificate

The RAC is a professional certification: A formal recognition by an established and credible professional organization that an individual has demonstrated proficiency within, and comprehension of, an identified body of knowledge.

To earn a RAC, you must demonstrate competency by passing an exam, administrated by an accredited third-party testing provider. Neither the RAC Program nor RAPS requires you to take specific training courses as a condition of awarding the RAC credential; it is based solely on your exam performance.

What the RAC is not – A RAC is not a certificate, a document awarded for the attainment or completion of a series of courses or verification of attendance or participation in a learning event. Certificates do not have ongoing maintenance or renewal requirements and a certificate is not a precursor to certification.

The RAC Program is guided by the Regulatory Affairs Certification Board (RACB) and independent exam committees.

Download RAC Autumn Candidate Guide
Certification vs. Credential
Contact RAPS about the RAC