The Regulatory Affairs Certification (RAC) is a professional credential administered by the Regulatory Affairs Professionals Society (RAPS) for individuals working in healthcare-product regulatory affairs — the function responsible for taking drugs, biologics, and medical devices through agency review and keeping them compliant after approval.
It is not a research-ethics or human-subjects credential like GCP certification, and it is not issued or required by FDA, EMA, or any other regulator. RAC sits adjacent to research administration — relevant to clinical-research, technology-transfer, and compliance staff whose work touches product regulatory strategy — rather than at its center. This guide explains what RAC is, who administers it, its two designations, eligibility and exam structure, recertification, and how it differs from adjacent research-administration credentials.
What RAC is, and what it isn’t
RAC is a knowledge-based certification exam, not a training course or a license to practice. RAPS describes it as the credential validating expertise for professionals working in regulatory agencies, industry, and consultancies focused on healthcare-product oversight — pharmaceuticals, biologics, and medical devices, across the full product lifecycle from early development through post-market surveillance. Holding it demonstrates that a candidate has met a defined bar of regulatory knowledge and experience; it does not authorize anyone to practice regulatory affairs the way a professional license would, because no such license exists in this field. Source: RAPS, “What Is the RAC?” (raps.org/certifications/rac/what-is-the-rac).
This distinguishes RAC from compliance training that research institutions mandate directly, such as CITI Program human-subjects or GCP coursework, or RCR training required by NIH and NSF. Those are institutional or funder mandates tied to a specific protocol or award. RAC is a voluntary, individually-held professional credential — closer in kind to a bar exam for a specialty field than to mandatory research-compliance training, though an institution’s regulatory affairs office may still value or informally expect it of senior staff.
Who administers it
RAPS (Regulatory Affairs Professionals Society) owns and administers the RAC program: it sets eligibility criteria, publishes the exam content outline, manages testing windows, and governs recertification. Exam delivery itself runs through Pearson VUE, at Pearson’s global network of testing centers or via online proctoring (OnVUE). RAPS is a member-based professional society for the regulatory affairs field, not a government body — the same relationship ACRP has to its CCRC/CCRA credentials or SOCRA has to CCRP in the clinical-research-coordination space. Source: RAPS, “What Is the RAC?” (raps.org/certifications/rac/what-is-the-rac).
The two designations: RAC-Drugs and RAC-Devices
RAPS offers two separate RAC exams, and a candidate can hold either or both:
- RAC-Drugs — for regulatory professionals working on pharmaceuticals and biologics.
- RAC-Devices — for regulatory professionals working on medical devices and in vitro diagnostics.
Each exam is built around critical thinking about regulatory challenges across a product’s lifecycle — development, submission, approval, and post-market obligations — within its respective product category, rather than testing the regulations of a single country in isolation; candidates are still expected to know the specific frameworks (e.g., FDA pathways, or the jurisdiction the candidate practices in) that apply to their own work. There is a separate, related credential — the Regulatory Compliance Certification for in vitro diagnostics (RCC-IVDR) — that RAPS also administers for EU IVDR-specific compliance work; it is distinct from RAC-Devices. Source: RAPS RAC-Drugs and RAC-Devices candidate guides (raps.org/rac-drugs-candidate-guide, raps.org/rac-devices-candidate-guide).
RAC Certification Requirements
A candidate qualifies for either RAC exam by meeting one of these thresholds:
- Bachelor’s degree (or equivalent) plus a minimum of 3 years of regulatory experience
- Master’s degree plus a minimum of 2 years of regulatory experience
- Doctorate plus a minimum of 1 year of regulatory experience
- A minimum of 10 years of regulatory-related experience, regardless of formal degree
Qualifying “regulatory-related experience” is defined broadly — it includes quality assurance, quality control, and clinical-research work tied to the approval of health products, as well as regulatory project management, not only work with the title “regulatory affairs” attached. This is relevant to research administrators: staff who have spent years in clinical-trial regulatory submissions, IND/IDE support, or product-approval-adjacent compliance work may already meet the experience bar even without a formal regulatory-affairs job title. Source: RAPS RAC eligibility criteria (raps.org/certifications/rac/what-is-the-rac).
Exam structure and testing windows
RAC exams run in three annual testing windows — typically spring, summer, and autumn — scheduled through Pearson VUE, either in person at a testing center or remotely via online proctoring. Starting with the Spring 2026 testing window, RAPS expanded the RAC exam from 100 questions in 2 hours to 120 questions in 2.5 hours. Results are typically released roughly 12 weeks after a testing window closes, reflecting the psychometric scoring and standard-setting work RAPS performs across each full cohort rather than same-day automated scoring. Because exam length and format are set by RAPS and can change between cycles, candidates should confirm current specifications on the relevant RAC candidate guide (raps.org/rac-drugs-candidate-guide or raps.org/rac-devices-candidate-guide) before registering, rather than relying on a prior year’s format.
Recertification
RAC is not a one-time credential. RAPS requires recertification every three years, which credential holders satisfy by earning 36 RAC recertification credits within that cycle — through continuing education, professional writing, public speaking, or participation in regulatory professional organizations. Credits earned in one three-year cycle do not carry over into the next. This is directionally consistent with how adjacent research-compliance credentials operate (for example, GCP certification providers and clinical-research coordinator credentials both use multi-year renewal cycles tied to continuing education), though the specific credit count and cycle length are RAC-specific; confirm current recertification requirements directly against RAPS’s recertification guidance (raps.org/certifications/rac/recertification) before relying on a specific figure, as continuing-education policy is the kind of detail a credentialing body can revise between cycles.
Who typically needs it
RAC is most directly relevant to regulatory affairs staff at pharmaceutical, biologic, and medical-device companies, and at the consultancies and CROs that support them — people whose job is preparing and managing agency submissions (e.g., INDs, NDAs, BLAs, 510(k)s, PMAs) and post-market regulatory compliance. Within research administration specifically, it is most relevant to:
- Institutional regulatory affairs staff supporting investigator-initiated studies that require an FDA IND or IDE, where the same person effectively performs a sponsor-side regulatory-affairs role on behalf of the institution.
- Technology-transfer and licensing staff working on the regulatory pathway for a spinout or licensed product — understanding FDA/EMA submission requirements is directly relevant to structuring a license or evaluating a product’s commercialization timeline.
- Clinical-research compliance and quality staff whose responsibilities extend into product-level regulatory strategy rather than protocol-level human-subjects oversight.
It is not typically required of clinical research coordinators, IRB staff, or grants administrators, whose work sits in human-subjects protection and award administration rather than product regulatory strategy — those roles are better served by credentials like GCP certification, CITI human-subjects training, or an IRB-specific credential.
How RAC differs from adjacent credentials
RAC is frequently confused with, or asked about alongside, several other credentials that occupy nearby but distinct territory in clinical research and compliance:
- RAC vs. Clinical Research Associate (CRA) credentials — a CRA credential (such as ACRP’s CCRA) certifies competency in clinical-trial monitoring: site visits, protocol adherence, data verification. RAC certifies competency in product regulatory strategy and submissions. A CRA typically monitors whether a trial is being run correctly against a protocol; a regulatory affairs professional typically manages what has to be submitted to, and negotiated with, a regulator to run or approve that product at all. The two functions can sit in the same department but test different competencies.
- RAC vs. CIP (Certified IRB Professional) — CIP, administered by PRIM&R’s Council for Certification of IRB Professionals, certifies competency in human-subjects ethics review and IRB administration. It has no product-regulatory-submission content. RAC has no human-subjects-ethics content. An institution’s IRB office and its regulatory affairs office are typically distinct functions, each with its own relevant credential.
- RAC vs. CCRP (SOCRA) — the Society of Clinical Research Associates’ Certified Clinical Research Professional credential, like CRA credentials generally, focuses on clinical-trial conduct and coordination rather than regulatory submissions strategy.
- RAC vs. GCP certification — GCP certification (via providers such as CITI, ACRP, or SOCRA) demonstrates familiarity with the ICH E6 principles governing how a clinical trial should be conducted and documented. It is commonly required of anyone with a direct role in running a trial. RAC demonstrates competency in the separate discipline of getting a product through regulatory review and keeping it compliant post-approval. A single professional working in institutional clinical-trials regulatory support may reasonably hold both.
Frequently asked questions
Is RAC required to work in regulatory affairs?
No. RAC is a voluntary, individually-held professional credential, not a legal or regulatory requirement to practice or to be employed in a regulatory affairs role. Employers may prefer or require it for certain positions as a hiring or advancement standard, but no government body mandates it.
Can I hold both RAC-Drugs and RAC-Devices?
Yes. They are separate exams with separate eligibility review and separate recertification tracking, and a professional whose work spans both product categories can pursue both.
Does RAC expire?
Yes — RAC operates on a recertification cycle rather than being permanent once earned; holders must accrue continuing-education credits within each cycle to maintain the credential. See the Recertification section above, and confirm the current cycle length and credit requirement directly with RAPS before relying on a specific figure.
Is RAC the same everywhere, regardless of country?
The RAC-Drugs and RAC-Devices exams are administered globally through RAPS and Pearson VUE, but each exam is built around the regulatory frameworks relevant to the candidate’s practice, and RAPS advises candidates to be thoroughly familiar with the regulatory environment of the jurisdiction they work in. It is not a single, jurisdiction-neutral test of one universal regulatory code.
