The RAC-US exam, officially titled Regulatory Affairs Certification (RAC) US, is the qualifying exam for the Regulatory Affairs Certification US (RAC-US) certification, which sits at the Professional level. Earning it shows employers that you have the skills the credential stands for, and it is a solid step forward on a RAPS career path. It also connects to RAC-EU, RAC-Drugs, RAC-Devices, RAC-Global, so the effort you put in now keeps paying off as you advance.

The RAC-US exam gives you 100 questions to complete within 120 minutes. Do the math before exam day: divide the total time by the question count to set a steady per-question pace, and flag any item that stalls you so you can return to it after securing the easier points. The most reliable way to build that rhythm is a full timed practice test under the same limit, which is exactly what TestSimulate's test engines are designed for.

The passing score for RAPS Regulatory Affairs Certification (RAC) US is Scaled score 70 (range 0–99), and the official registration fee is Member: $605 USD; Non-Member: $760 USD (2026 rates). Keep in mind that a retake means paying that fee again in full, which makes an honest self-check worthwhile: before you book, sit a timed practice test and make sure you are consistently scoring above the passing line with some margin to spare.

According to the official requirements: Bachelor's + 3 years experience; Master's + 2 years; Doctorate + 1 year; or 10+ years regulatory experience. Eligibility rules do change from time to time, so confirm the current details on the official exam page before you register.

Registration for the RAC-US exam is handled through the official channels below:

• RAPS RAC Application Portal

The exam is delivered in the following format: Online remote proctored or in-person at authorized testing centers. Pick a date that leaves room for at least one full timed practice test beforehand.

RAPS recommends the following official training options for candidates preparing for RAPS Regulatory Affairs Certification (RAC) US:

• RAPS Official RAC Preparation Resources
• RAC-US Candidate Guide

Courses build the foundation, but they work best alongside question practice. That is where TestSimulate comes in: the 100 practice questions in our RAC-US package let you rehearse the exam format at your own pace and see exactly where you stand.

Yes — TestSimulate offers a free PDF demo of the RAPS Regulatory Affairs Certification (RAC) US material, so you can review the question style and answer quality before you spend anything. After purchase, you also receive 365 days of free updates, and if your product expires you can extend the update service at a 50% discount from your member zone.

If you take the corresponding exam within 60 days of your purchase and do not pass, you are covered by the 100% Money Back Guarantee under clear conditions. To claim a full refund, submit a scan of your exam enrollment slip and your official Score Report PDF within two days of the exam; requests are processed within seven days. Note that sitting the exam within three days of purchase is not eligible, purchases that were never followed by an exam sitting do not qualify, free materials and expired orders are excluded, and the candidate name must match the payer name. Prefer an exchange instead? You can swap your product for two free exam packages of equal value and keep your update service. Delivery is immediate: your RAC-US material is ready for instant download and is also emailed to you within one minute of payment — contact customer service if nothing arrives within two hours. There is no limit on the number of computers you can install it on.

The current RAPS Regulatory Affairs Certification (RAC) US syllabus is organized into 4 exam domains. The first three are:

• Development and Pre-Market (28%)
• Post-Market and Compliance (24%)
• Strategic Planning (24%)

For the full domain and subtopic breakdown, see the Exam Topics section above — that is the outline your TestSimulate practice questions are mapped to.