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- Total Questions: 100
- Updated on: Oct 22, 2026
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- Total Questions: 100
- Updated on: Oct 22, 2026
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A bad result on the RAC-GS exam costs the fee, the wait, and the confidence. The RAPS Regulatory Affairs Certification (RAC) Global Scope practice set from Exams4sures — 100 questions — exists so your first result is your only result.
RAPS RAC-GS Exam Overview:
| Certification Vendor: | Regulatory Affairs Professionals Society (RAPS) |
|---|---|
| Exam Name: | Regulatory Affairs Certification (RAC) Global Scope Exam |
| Exam Number: | RAC-GS |
| Exam Price: | $605 (RAPS Member), $760 (Non-Member) - 2026 rates |
| Passing Score: | 70% |
| Certificate Validity Period: | 3 years |
| Exam Duration: | 210 minutes |
| Real Exam Qty: | 150-180 |
| Available Languages: | English |
| Related Certifications: | RAC-Drugs RAC-Devices |
| Exam Format: | Recall, Application, Computer-Based, Multiple Choice, Analysis |
| Recommended Training: | RAPS Online University RAPS Fundamentals Textbooks |
| Exam Registration: | RAPS Official Application Pearson VUE Scheduling |
| Sample Questions: | DOWNLOAD DEMO |
| Exam Way: | Computer-based testing at Pearson VUE centers or online remote proctoring |
| Pre Condition: | Bachelor's degree + 3 years regulatory experience; Master's + 2 years; Doctorate + 1 year; RAPS membership recommended |
| Official Syllabus URL: | https://www.raps.org/certifications/rac |
RAPS RAC-GS Exam Syllabus Topics:
| Section | Weight | Objectives |
|---|---|---|
| Topic 1: Global Regulatory Environment & Strategy | 35% | - Regulatory Strategy & Planning
|
| Topic 2: Regulatory Submissions & Approval | 20% | - Review Process & Interactions
|
| Topic 3: Product Development & Lifecycle Management | 25% | - Chemistry, Manufacturing & Controls
|
| Topic 4: Post-Market Compliance & Surveillance | 20% | - Pharmacovigilance & Adverse Events
|
RAPS Regulatory Affairs Certification (RAC) Global Scope FAQ: Answers That Matter
The official fee is $605 (RAPS Member), $760 (Non-Member) - 2026 rates per attempt, and the passing score is 70%. A failed attempt means paying the entire fee again — which makes the 100 practice questions from Exams4sures the cheaper rehearsal. Self-test until the pass mark feels routine, then book.
Your files arrive fast: successful payment triggers an automatic email within a minute, with instant download access and no installation limits — our 24/7 customer assistance handles anything still missing after 2 hours. And failure isn't the end: take the corresponding RAC-GS exam within 60 days of purchase, and if you don't pass, submit a scanned enrollment slip plus the official Score Report PDF within 2 days of the exam for a full refund processed within 7 days. Exclusions: exams within 3 days of purchase, name mismatches between candidate and payer, and free or expired products. You can also choose to change to two other equal-value exam products free instead of the refund.
The RAPS Regulatory Affairs Certification (RAC) Global Scope blueprint spans 4 domains — among them Post-Market Compliance & Surveillance (20%), Regulatory Submissions & Approval (20%), Product Development & Lifecycle Management (25%). Weightings are the vendor's way of saying where points concentrate, so budget your time accordingly. The full outline above details every subtopic.
Yes — download the free trial before you buy and check the question quality yourself. Purchases include 365 days of free updates, and if your update period expires later, renew it at half price.
Yes:
Courses teach; questions test. After finishing any training, run the RAC-GS practice questions from Exams4sures to verify what actually stuck.
Bachelor's degree + 3 years regulatory experience; Master's + 2 years; Doctorate + 1 year; RAPS membership recommended Since vendors revise eligibility rules, confirm the current requirements on the official exam page (official RAC-GS exam page) before registering.
Registration goes through the vendor's official channels:
The exam runs Computer-based testing at Pearson VUE centers or online remote proctoring, so choose the arrangement that suits you when booking.
The RAPS Regulatory Affairs Certification (RAC) Global Scope is RAPS's official exam for the Regulatory Affairs Certification (RAC) Global Scope certification, at the Professional level. It tests real professional knowledge and experience — that's why it's considered difficult, and why the credential means something. It also connects to related credentials like RAC-Drugs, RAC-Devices.
You'll get 210 minutes for 150-180 questions. Lack of time sinks more candidates than lack of knowledge — so build your pacing now: set a per-question budget, practice flagging hard items, and run full timed sessions in the Exams4sures engine until the clock feels like an ally.
RAPS Regulatory Affairs Certification (RAC) Global Scope Sample Questions:
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. Strengthening a precaution to the product labeling
- D. Introducing a new analytical method
Correct Answer: C 🗳️
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.
Correct Answer: B 🗳️
During several monitoring visits, a clinical trial monitor identifies serious and repeated noncompliance on the part of the PI. What action should the sponsor take?
- A. Increase the frequency of monitoring visits.
- B. Send a letter of complaint to the Ethics Committee that approved the site.
- C. Terminate the PI and inform the regulatory authorities.
- D. Inform the institution that granted a medical license to the Pi.
Correct Answer: C 🗳️
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. Local reimbursement requirements
- C. Service operation procedures
- D. Training program for sales people
Correct Answer: D 🗳️
Why is it necessary to run supplemental safety pharmacology studies?
- A. To comply with regulatory authority requirements related to clinical studies
- B. To provide adverse reaction reports and the results of the statistical data to the regulatory authority
- C. To substitute the utilization of GLP
- D. To evaluate potential adverse pharmacodynamics effects not addressed by the core battery
Correct Answer: D 🗳️
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