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RAPS RAC-US Exam Overview:
| Certification Vendor: | Regulatory Affairs Professionals Society (RAPS) |
|---|---|
| Exam Name: | Regulatory Affairs Certification (RAC) United States |
| Exam Number: | RAC-US |
| Available Languages: | English |
| Passing Score: | Scaled score 70 (range 0–99) |
| Related Certifications: | RAC-Global RAC-Drugs RAC-EU RAC-Devices |
| Real Exam Qty: | 100 |
| Certificate Validity Period: | 3 years (requires recertification) |
| Exam Price: | Member: $605 USD; Non-Member: $760 USD (2026 rates) |
| Exam Duration: | 120 minutes |
| Exam Format: | Multiple-choice, Application, Computer-based, Recall, Analysis |
| Recommended Training: | RAPS Official RAC Preparation Resources RAC-US Candidate Guide |
| Exam Registration: | RAPS RAC Application Portal |
| Sample Questions: |  |
| Exam Way: | Online remote proctored or in-person at authorized testing centers |
| Pre Condition: | Bachelor's + 3 years experience; Master's + 2 years; Doctorate + 1 year; or 10+ years regulatory experience |
| Official Syllabus URL: | https://www.raps.org/certifications/rac/rac-us |
RAPS RAC-US Exam Syllabus Topics:
| Section | Weight | Objectives |
|---|---|---|
| Submissions and Regulatory Interactions | 24% | - FDA review processes and communications - Regulatory intelligence and planning - Modifications, supplements, and variations - eCTD and electronic submission formats |
| Development and Pre-Market | 28% | - CMC and manufacturing requirements - Clinical trials and non-clinical studies - Labeling and advertising regulations - Design controls and technical documentation |
| Strategic Planning | 24% | - US regulatory environment and framework - Regulatory pathways and marketing authorization - Risk management and quality systems - Product lifecycle strategy |
| Post-Market and Compliance | 24% | - Reporting obligations and adverse events - Inspections, audits, and enforcement actions - Post-marketing surveillance and pharmacovigilance - Compliance and continuous improvement |
RAPS Regulatory Affairs Certification (RAC) US (RAC-US) — Questions Candidates Actually Ask
The RAC-US exam, officially known as RAPS Regulatory Affairs Certification (RAC) US, is the RAPS test that leads to the Regulatory Affairs Certification US (RAC-US) certification at the Professional level. Passing it validates the skills employers expect from a certified professional. It is also associated with related credentials such as RAC-EU, RAC-Drugs, RAC-Devices, RAC-Global.
The RAC-US exam contains 100 questions, and you have 120 minutes to complete them. Work out your per-question pace before test day, and flag slow items instead of stalling on them — time pressure, not knowledge, sinks many first attempts. Timed mock exams in the Actual4Exams test engines are the most reliable way to build that rhythm.
The passing score for the RAC-US exam is Scaled score 70 (range 0–99), and the official registration fee is Member: $605 USD; Non-Member: $760 USD (2026 rates). If you miss the mark, a retake means paying the full fee again, so book your seat only when you are ready. A practical benchmark: score consistently above the passing line on timed practice tests before scheduling the real exam.
Bachelor's + 3 years experience; Master's + 2 years; Doctorate + 1 year; or 10+ years regulatory experience
Entry requirements can change, so confirm the latest conditions on the official exam page: https://www.raps.org/certifications/rac/rac-us.
You can book the RAC-US exam through the official registration channels below:
Exam delivery: Online remote proctored or in-person at authorized testing centers. Seats at popular test centers fill quickly, so schedule early once your preparation is on track.
RAPS recommends the following training options for RAPS Regulatory Affairs Certification (RAC) US candidates:
Pair any course with the 100 practice questions from Actual4Exams to measure how ready you really are before paying the exam fee.
Yes. A free PDF demo of the RAPS Regulatory Affairs Certification (RAC) US questions is available, so you can check the question style and answer quality before you pay. Every purchase also includes 365 days of free updates, and if the product expires you can renew the update service at a 50% discount from your member zone.
If you take the corresponding RAC-US exam within 60 days of purchase and do not pass, you can apply for a full refund under the 100% Money Back Guarantee: submit a scan of your enrollment slip and your official Score Report (PDF) within 2 days of the exam date, and the claim is processed within 7 days. Attempts made within 3 days of purchase, downloads without an actual exam attempt, free materials, and expired orders are not eligible, and the candidate name must match the payer name. Prefer new material instead of a refund? You can exchange your purchase for two free products of equal value and keep the update service on your original product. As for delivery, the files are available for instant download and are also emailed to you within one minute of payment — if nothing arrives within 2 hours, contact customer service. There is no limit on how many computers you can install the product on.
The official RAPS Regulatory Affairs Certification (RAC) US outline is organized into 4 domains. The first three are:
- Submissions and Regulatory Interactions — 24% of the exam
- Post-Market and Compliance — 24% of the exam
- Development and Pre-Market — 28% of the exam
See the complete exam topics section above for the full outline and the weighting of every domain.
RAPS Regulatory Affairs Certification (RAC) US Sample Questions:
Question 1
Which term does NOT describe the same concept as the others?
A. Subsequent entry biologics
B. Follow-on protein products
C. Biosimilars
D. Monoclonal antibody
Question 2
According to the GHTF IVD guidance, which of the following is the CORRECT classification for a blood glucose self-testing kit?
A. Class D
B. Class B
C. Class A
D. Class C
Question 3
A drug product presents degradation during the manufacturing process. In addition to the amount, what information should be provided FIRST in order to use API overage?
A. Property
B. Justification
C. Specification
D. Formulation
Question 4
A manufacturer is involved in a recall event process for a plasma-derived product. From which stage should the manufacturer be able to trace back the product?
A. Individual plasma donation
B. Product distribution
C. Plasma fractionation
D. Plasma pooling
Question 5
According to ICH, which of the following components of study information is NOT required in a clinical study report?
A. Protocol and protocol amendments
B. Randomization scheme and codes
C. Detailed CV of all investigators
D. List of lECs or lRBs
Solutions:
| Question 1 Answer: D | Question 2 Answer: D | Question 3 Answer: B | Question 4 Answer: B | Question 5 Answer: C |
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This means that if due to any reason you are not able to pass the RAC-US actual exam even after using our product, we will reimburse the full amount you spent on our products. you just need to mail us your score report along with your account information to address listed below within 7 days after your unqualified certificate came out.
