What is RAC and who is it for?
RAC is the Regulatory Affairs Certification, awarded through the Regulatory Affairs Professionals Society and its certification board, and it is the recognised credential for the profession that gets medical products lawfully to market and keeps them there. Regulatory affairs professionals prepare submissions, interpret evolving regulation, manage interactions with health authorities, oversee labelling and advertising compliance, handle post-market obligations including adverse event reporting and recalls, and advise development teams on what evidence a regulator will actually require. The certification is not a single generic examination: the board differentiates by product scope, most importantly between medicinal products and medical devices, because the regulatory frameworks governing them differ fundamentally, and jurisdictional variants exist. Eligibility combines education with documented regulatory experience on a sliding scale, so a candidate with a higher degree needs fewer years than one entering from another route. Certification runs on a three-year cycle maintained by accumulating recertification credits from professional development, education and contribution to the profession.
- RAC is awarded through RAPS and differentiates its examinations by product scope rather than testing one generic body of knowledge.
- Eligibility trades academic qualification against documented regulatory affairs experience specifically defined by the board.
- No law requires the credential — health authorities regulate companies and products, not individual filers.
- Certification runs three years and is maintained by accumulating recertification credits rather than retesting.
RAC at a glance
| Cost | Examination and recertification fees are set by the certifying body and priced differently for society members — consult its current fee schedule |
| Duration | A single computer-based examination, taken after the required combination of education and regulatory experience |
| Issued by | Regulatory Affairs Professionals Society, through its regulatory affairs certification board |
| Format | Computer-based multiple-choice examination differentiated by product scope |
| Expiry | 3-year cycle maintained by accumulating recertification credits |
| Who needs it | Regulatory affairs professionals in pharmaceutical, biotechnology, medical device, diagnostics and combination product organisations, plus consultancies and notified bodies |
| Scope split | Examinations are differentiated by product scope — most importantly medicinal products versus medical devices — with jurisdictional variants |
| Eligibility | A sliding combination of academic qualification and documented regulatory affairs experience |
Sources: Regulatory Affairs Professionals Society — RAC credential · RAPS — RAC recertification. Reviewed August 2026 by the GlobalCybers team.
Product Scope, Eligibility Trade-Offs and Exam Content
Choose the scope that matches your work
The board offers examinations differentiated by product scope rather than one generic test, because drug and device regulation are structurally different — different approval pathways, different evidence expectations, different post-market obligations. Jurisdictional variants also exist. Because the certifying body periodically revises its examination lineup, candidates should confirm the current offering with the board before committing to a preparation programme built around an older structure.
Eligibility and what is tested
Where RAC fits in a regulatory affairs career
Regulatory affairs professionals are counted within compliance occupations in federal wage statistics, which understates how specialised the work is. The credential's role is to make an otherwise opaque profession legible: people enter regulatory affairs from science, quality, clinical and legal backgrounds with no common qualification, and certification is the shared external benchmark hiring managers use.
GlobalCybers reimburses certification fees after a successful permanent placement through our network.
What RAC Covers, Submissions Through Post-Market
Regulatory Strategy
Choosing a pathway, sequencing evidence generation, anticipating what a health authority will ask, and telling a development team what its design decision has just cost.
Submissions
Application types and their content and format requirements, assembling a dossier that reviewers can navigate, and managing questions during review.
Labelling & Promotion
What a label may claim and on what evidence, promotional review, off-label communication boundaries and the discipline of substantiation.
Quality Interface
How manufacturing changes, design controls and quality system findings become regulatory events, and when a change requires notification or approval.
Post-Market
Surveillance obligations, adverse event and vigilance reporting timelines, field safety actions and recall classification and execution.
Jurisdictional Difference
Why the same product faces different requirements in different markets, and how global regulatory plans are sequenced rather than duplicated.
How do you get RAC certified, step by step?
Confirm the current examination lineup and choose your scope
The certifying body has revised its examination structure over time, so start from its current published offering rather than from an older description. Then pick the scope matching your actual work — device professionals sitting a medicinal products examination, or the reverse, are preparing for a different regulatory world.
Check your experience against the board's definition
The eligibility scale trades academic qualification against years, but the years must be regulatory affairs experience as the board defines it. Adjacent work in quality assurance, clinical operations or general compliance may not count, and this is the most common reason an application is refused.
Study the framework, not your company's habits
Long-serving regulatory professionals know their own products, markets and internal processes intimately and can be weak on pathways they have never used. The examination covers the framework as a whole, so deliberately study submission types, post-market obligations and jurisdictional arrangements outside your daily experience.
Sit the examination and start accruing recertification credits
The credential runs on a three-year cycle maintained by accumulating credits from professional development, education, and contribution such as speaking, writing or volunteering with the profession. Log activity as you complete it; reconstructing three years of credits from memory is the usual reason a lapse happens.
Regulators Regulate Products, Not the People Who File
No law requires a regulatory affairs professional to hold this or any credential — health authorities regulate products and manufacturers, and hold the company accountable for what it submits. The certification is instead the profession's own answer to a recruitment problem: there is no licence, no required degree and no standard entry route, so employers and consultancies use certification as the external signal that a candidate understands the framework rather than only their previous employer's procedures.
RAC, Frequently Asked Questions
RAC certified? Regulatory teams are competing for you.
Pharmaceutical, device and diagnostics organisations are all short of experienced regulatory professionals. Set your product scope and let them find you.
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