Exam Name: Regulatory Affairs Certification (RAC) US
Certification Provider: RAPS
Corresponding Certification: RAC Regulatory Affairs Certification
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Updated: Aug 31, 2026
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RAPS RAC-US Exam Overview:
| Certification Vendor: | Regulatory Affairs Professionals Society (RAPS) |
|---|---|
| Exam Name: | Regulatory Affairs Certification (RAC) US |
| Exam Number: | RAC-US |
| Real Exam Qty: | 100 |
| Exam Duration: | 120 minutes |
| Related Certifications: | RCC RAC-Global RAC-Canada RAC-EU |
| Passing Score: | Scaled score of 75 |
| Exam Format: | Recall, Analysis, Application, Multiple-choice, Computer-based |
| Exam Price: | USD 605 (RAPS Member), USD 760 (Non-Member) |
| Available Languages: | English |
| Certificate Validity Period: | 3 years |
| Sample Questions: | DOWNLOAD DEMO |
| Exam Way: | Pearson VUE Test Center or Online Proctored Exam (OnVUE) |
| Pre Condition: | Bachelor's degree and 3 years regulatory experience; or Master's degree and 2 years regulatory experience; or Doctorate degree and 1 year regulatory experience. |
| Official Syllabus URL: | https://www.raps.org/certifications/rac |
RAPS RAC-US Exam Syllabus Topics:
| Section | Objectives |
|---|---|
| Interfacing with Regulatory Agencies | - Regulatory communication and negotiation
|
| Strategic Planning | - Regulatory strategy development
|
| Post-Approval and Lifecycle Management | - Marketed product compliance
|
| Premarketing | - Product development and approval
|
FAQs for RAPS Regulatory Affairs Certification (RAC) US Candidates
The RAC-US exam leads to the RAC Regulatory Affairs Certification certification from Regulatory Affairs Professionals Society (RAPS). It is positioned at the Professional level. The exam validates the knowledge and skills expected of candidates preparing for RAPS Regulatory Affairs Certification (RAC) US.
Related certifications include:
- RAC-Global
- RAC-EU
- RAC-Canada
- RCC
The RAC-US exam includes 100 questions and allows 120 minutes. Before test day, divide the available time by the number of questions in a timed practice set to establish a steady per-question pace. If a difficult item starts consuming too much time, mark it for review and move forward instead of losing momentum. A full timed practice session can help you decide when to move on, when to return, and how much buffer to reserve for a final check.
The passing score for RAC-US is Scaled score of 75, and the official exam fee is USD 605 (RAPS Member), USD 760 (Non-Member). Because a retake requires paying the exam fee again, use timed practice results as a readiness check before scheduling your next attempt. If your performance remains inconsistent, continue reviewing weak domains and repeat a timed session before booking the exam.
Bachelor's degree and 3 years regulatory experience; or Master's degree and 2 years regulatory experience; or Doctorate degree and 1 year regulatory experience.
Eligibility rules can change, so confirm the current requirements on the official exam page before registering.
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The current RAC-US outline is organized into 4 top-level domains. The first listed areas include:
- Strategic Planning
- Post-Approval and Lifecycle Management
- Interfacing with Regulatory Agencies
Review the Exam Topics section above for the complete outline and any nested subtopics.
RAPS Regulatory Affairs Certification (RAC) US Sample Questions:
Question 1
You discover that your company's top selling product in the last two years has been used off-label.
The off-label use is estimated to be about 70%, and it has been consistent since the product was first released to the market. Which of the following is MOST appropriate?
A. File a report to regulatory authorities and advise the marketing department to prevent future off-label use.
B. Discuss with regulatory authorities to investigate how to have the off-label indication approved.
C. Advise the senior management to send a "Dear Dr." letter.
D. No action is required since it is an off-label use.
Question 2
In a distribution contract for high-risk medical devices, which of the following regulatory requirements is the MOST important for the distributor?
A. Written procedure for product traceability
B. Training program for sales people
C. Service operation procedures
D. Local reimbursement requirements
Question 3
The API used for an approved drug product conforms to international monograph specifications and local pharmacopeia; however, the international monograph specifications of the API will be changing soon. Which is the most appropriate action for the regulatory affairs professional to take FIRST?
A. Transfer the notice of the upcoming international monograph change to QA for further processing.
B. Prepare the international monograph change submission first and then prepare the local change when required.
C. Confirm that the international monograph change is not related to local pharmacopeia.
D. Analyze the impact of the international monograph change on the local pharmacopeia.
Question 4
Which of the following is MOST appropriate for the purpose of lot release of biologics?
A. Safety assurance
B. Inventory control
C. Quality verification
D. Efficacy confirmation
Question 5
During a routine review of promotional materials for a product, a regulatory affairs professional discovers an off-label indication. Which of the following would be the FIRST follow-up action for the regulatory affairs professional to take?
A. Contact the marketing department to recall the product.
B. Allow doctors to use the product for the off-label indication.
C. Request that doctors stop using the product for the off-label indication.
D. Communicate with the sales department to stop using the promotional materials.
Solutions:
| Question 1 Answer: B | Question 2 Answer: B | Question 3 Answer: A | Question 4 Answer: C | Question 5 Answer: D |
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