Exam Name: Regulatory Affairs Certification (RAC) US
Certification Provider: RAPS
Corresponding Certification: RAC Regulatory Affairs Certification
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Instant Download RAPS : RAC-US Questions & Answers as PDF & Test Engine
Updated: Sep 17, 2026
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Good materials and good methods let you do more with less. In 2026, PassTestking applies that principle to the RAC-US exam: 100 practice questions mapped to the official outline, three versions to match any routine, and delivery by email within one minute of purchase.
RAPS RAC-US Exam Overview:
| Certification Vendor: | Regulatory Affairs Professionals Society (RAPS) |
|---|---|
| Exam Name: | Regulatory Affairs Certification (RAC) United States |
| Exam Number: | RAC-US |
| Exam Format: | Application, Recall, Multiple-choice, Computer-based, Analysis |
| Exam Duration: | 120 minutes |
| Passing Score: | Scaled score 70 (range 0–99) |
| Certificate Validity Period: | 3 years (requires recertification) |
| Related Certifications: | RAC-Global RAC-Devices RAC-Drugs RAC-EU |
| Real Exam Qty: | 100 |
| Exam Price: | Member: $605 USD; Non-Member: $760 USD (2026 rates) |
| Available Languages: | English |
| Recommended Training: | RAC-US Candidate Guide RAPS Official RAC Preparation Resources |
| Exam Registration: | RAPS RAC Application Portal |
| Sample Questions: | RAPS RAC-US 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 |
|---|---|---|
| Topic 1: Development and Pre-Market | 28% | - Design controls and technical documentation - Clinical trials and non-clinical studies - CMC and manufacturing requirements - Labeling and advertising regulations |
| Topic 2: Submissions and Regulatory Interactions | 24% | - FDA review processes and communications - Modifications, supplements, and variations - eCTD and electronic submission formats - Regulatory intelligence and planning |
| Topic 3: Post-Market and Compliance | 24% | - Inspections, audits, and enforcement actions - Reporting obligations and adverse events - Compliance and continuous improvement - Post-marketing surveillance and pharmacovigilance |
| Topic 4: Strategic Planning | 24% | - Regulatory pathways and marketing authorization - US regulatory environment and framework - Product lifecycle strategy - Risk management and quality systems |
RAC-US Exam Questions — Answered
Three full versions of the 100 practice questions for the RAPS Regulatory Affairs Certification (RAC) US exam, all in one moderately priced package: a printable, expert-prepared PDF with instant download; a Desktop Test Engine for Windows that simulates the real exam with two practice modes and works offline; and an Online Test Engine for any browser on Windows, Mac, Android, and iOS with test history and performance review. You also receive a free demo, 365 days of free updates, a 50% renewal discount afterward, and unlimited computer installations.
The passing score for the RAPS Regulatory Affairs Certification (RAC) US exam is Scaled score 70 (range 0–99), and registration runs Member: $605 USD; Non-Member: $760 USD (2026 rates). Retakes mean paying again, so it pays to check your readiness first — the PassTestking engines show your level honestly before you book.
RAPS recommends these training resources for the RAPS Regulatory Affairs Certification (RAC) US exam:
Combine the official training with the 100 practice questions from PassTestking — the questions reveal how well the training actually settled.
The RAPS Regulatory Affairs Certification (RAC) US exam gives you 120 minutes to answer 100. Time management is part of the test — rehearse with the timed mode in the PassTestking Desktop Test Engine until pacing becomes automatic.
Yes, under written conditions. Take the RAPS Regulatory Affairs Certification (RAC) US exam within 60 days of purchase, and if you do not pass, PassTestking refunds you in full. The policy does not apply if the exam is taken within 3 days of purchase, if the exam was never actually taken, or to free materials or expired orders, and the candidate name must match the payer name. Submit a scan of your enrollment slip and the official Score Report PDF within 2 days of the exam; claims are processed within 7 days. Alternatively, exchange for two free exam products of equal value while keeping your original update service. Orders are delivered by email within 1 minute — if nothing arrives within 2 hours, contact support.
The RAC-US exam is an official RAPS certification exam covering the RAPS Regulatory Affairs Certification (RAC) US syllabus detailed above. It counts toward these credentials: RAC-EU, RAC-Drugs, RAC-Devices, RAC-Global. As the certification grows more important in its field, the exam stays demanding — which is exactly why structured practice matters. PassTestking prepares you with 100 practice questions in PDF, Desktop Test Engine, and Online Test Engine formats.
Online remote proctored or in-person at authorized testing centers Sign up for the RAPS Regulatory Affairs Certification (RAC) US exam through these official channels:
Booked? Your PassTestking practice questions arrive by email within 1 minute, so the countdown to exam day can start immediately.
Bachelor's + 3 years experience; Master's + 2 years; Doctorate + 1 year; or 10+ years regulatory experience Since policies evolve, confirm the current requirements on the official RAPS exam page before scheduling.
The official RAPS Regulatory Affairs Certification (RAC) US outline defines 4 content domains. The three heaviest are Submissions and Regulatory Interactions (24%), Development and Pre-Market (28%), and Post-Market and Compliance (24%). The full list is in the topics section above, and the 100 practice questions at PassTestking cover each domain.
RAPS Regulatory Affairs Certification (RAC) US Sample Questions:
A regulation change is imminent and may require further non-clinical testing on a product currently in Phase III clinical trials. What is the most appropriate action to take FIRST?
- A. Inform the company's senior management and arrange an emergency meeting
- B. Obtain a copy of the proposed regulation and analyze the impact.
- C. Consult with the company's legal department regarding options.
- D. Arrange for additional testing of the product at the testing facility.
Correct Answer: B 🗳️
A protocol for a pivotal registration trial of a new product is submitted to a major regulatory authority for review and approval. The regulatory authority issues the company a written commitment that if the studies are completed as outlined in the protocol and the results meet the pre-specified criteria for efficacy and safety, the product will be approved.
During the final week of the review of the marketing application, which has fully met all pre- specified criteria, the company receives a letter from the regulatory authority stating that it no longer believes that the product will be approved based on a recent withdrawal of a similar product in another country.
What is the BEST response?
- A. Consult with the legal department to discuss the best course of action.
- B. Review the regulatory guidelines to determine how to proceed.
- C. Notify the regulatory authority regarding Its obligation to honor the commitment to approve the application.
- D. Request a meeting with the regulatory authority to discuss the application.
Correct Answer: D 🗳️
What is the BEST approach to ensure that raw materials, services, and sub-contractors at the level of the vendors comply with GMP requirements?
- A. Document and perform audits.
- B. Ask the vendor to take responsibility.
- C. Request documentation from the sub-contractor.
- D. Request an inspection from a regulatory authority.
Correct Answer: A 🗳️
Which of the following changes to a drug product is MOST likely to be implemented without prior regulatory authority approval?
- A. Deleting an ingredient of the drug product
- B. Deleting a drug substance
- C. Introducing a new analytical method
- D. Strengthening a precaution to the product labeling
Correct Answer: D 🗳️
What is the LAST stage in the development of a quality risk management process for a medical device?
- A. Risk evaluation
- B. Risk reduction
- C. Risk analysis
- D. Risk acceptance
Correct Answer: D 🗳️
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