The Regulatory Affairs Certification (RAC) is administered by the Regulatory Affairs Professionals Society (RAPS), the largest global organization dedicated to regulatory professionals in the health sciences sector. First introduced in 1992, the RAC has become the most widely recognized professional credential in regulatory affairs, held by thousands of professionals across more than 60 countries.
Unlike many certifications that focus on a single jurisdiction, the RAC family spans multiple regulatory environments. Candidates choose the variant that aligns with their professional focus — United States (FDA), European Union (EMA/competent authorities), or Canada (Health Canada). Each variant tests a distinct body of knowledge, though all share a common emphasis on strategic regulatory thinking, submission preparation, lifecycle management, and compliance.
The RAC is awarded by RAPS upon passing the relevant exam and meeting eligibility criteria. It signals to employers and regulators alike that the holder has demonstrated validated, practical expertise — not just theoretical knowledge — in navigating regulatory pathways for drugs, biologics, and medical devices.
RAPS currently offers three active RAC variants, each targeting a specific regulatory jurisdiction. Candidates may hold more than one variant if they meet the requirements for each.
RAC-US focuses on the United States regulatory environment governed by the FDA. It covers drug approvals (NDA, ANDA, BLA), medical device submissions (510(k), PMA, De Novo), combination products, post-market obligations, labeling requirements, and GMP/GCP compliance under CFR Title 21. Professionals working with FDA-regulated products — whether at manufacturers, CROs, or consulting firms — typically pursue this variant.
RAC-EU addresses the European regulatory framework, including the EU Medical Device Regulation (MDR 2017/745), In Vitro Diagnostic Regulation (IVDR 2017/746), and the centralized, decentralized, and mutual recognition procedures for medicinal products under EMA oversight. RAC-EU is essential for regulatory affairs managers at companies seeking CE marking or EMA approvals.
RAC-Canada covers Health Canada's regulatory requirements for pharmaceuticals (Part C of the Food and Drug Regulations), medical devices (Medical Devices Regulations SOR/98-282), and natural health products. It is the preferred credential for professionals managing Canadian submissions or seeking roles at Health Canada-regulated companies.
All RAC variants share the same eligibility framework, which combines academic education and professional work experience in regulatory affairs. RAPS uses a tiered system: candidates with more advanced degrees require fewer years of experience, and vice versa.
RAPS defines qualifying work experience as direct involvement in regulatory strategy, submission preparation, regulatory review, or regulatory compliance activities for health science products. Roles in adjacent areas such as quality assurance, clinical operations, or pharmacovigilance may qualify if regulatory affairs tasks were a primary component of the position.
There is no prerequisite course or training program required before applying — the RAC is an experience-based credential, not a course-completion credential.
To qualify for any RAC variant exam, candidates must meet the following combined education and experience thresholds set by RAPS:
Qualifying experience must be in a role where regulatory affairs was a primary function — including submission preparation, regulatory strategy, lifecycle management, or regulatory compliance for FDA-, EMA-, or Health Canada-regulated products. Part-time experience is prorated. Volunteer regulatory work may qualify if documented. RAPS reviews all applications individually; borderline experience is evaluated case by case.
Documentation required at application: employer name, job title, dates of employment, and a brief description of regulatory duties. RAPS may request additional verification for applications that do not clearly demonstrate regulatory affairs as a primary job function.
The RAC application is submitted through the RAPS website at raps.org. The process involves six steps:
If you do not pass on the first attempt, RAPS allows retakes. Candidates must wait a minimum of 90 days before retesting, and the standard exam fee applies to each attempt. There is no limit on the total number of attempts.
The RAC exam tests applied knowledge, not memorization. RAPS publishes an official RAC Exam Blueprint for each variant, outlining the major content domains and their relative weight on the exam. Reviewing the blueprint is the essential first step in any study plan.
Effective preparation strategies include:
Most candidates report studying between 100 and 200 hours over 3–6 months. Candidates with recent, broad regulatory experience tend to require less preparation time than those who have worked in a narrow regulatory subspecialty.
Regulatory affairs is one of the most consistently in-demand specialties in the life sciences industry. Companies in pharma, biotech, and medical devices must maintain a qualified regulatory function at every stage of the product lifecycle — from early development through commercialization, post-market surveillance, and product changes. This structural demand keeps salaries strong and job security high.
According to RAPS compensation surveys and industry salary data, regulatory affairs professionals in the United States earn:
Professionals holding the RAC credential consistently earn 10–20% more than their non-certified peers at equivalent experience levels, according to RAPS annual salary surveys. The premium is largest in senior individual contributor and management roles, where employers use RAC status as a proxy for demonstrated regulatory judgment.
Beyond salary, RAC holders benefit from stronger job mobility. The credential is recognized by employers globally, making it particularly valuable for professionals who work across multiple regulatory jurisdictions or who consult for multiple clients. In hiring decisions, the RAC frequently differentiates finalists in competitive regulatory roles.
Maintaining your RAC: certification must be renewed every 3 years. Renewal requires 30 RAC Credits earned through continuing education — RAPS conferences, webinars, courses, publications, and professional service all qualify. There is no re-examination requirement for renewal, making the ongoing credential maintenance relatively straightforward for active professionals.