Failing the RAC-GS exam means paying the full registration fee again. A focused run through the 100 RAPS Regulatory Affairs Certification (RAC) Global Scope practice questions at Actual4Exams is a far cheaper way to walk into the testing center prepared.
RAPS RAC-GS Exam Overview:
| Certification Vendor: | Regulatory Affairs Professionals Society (RAPS) |
|---|---|
| Exam Name: | Regulatory Affairs Certification (RAC) Global Scope |
| Exam Number: | RAC-GS |
| Passing Score: | Scaled pass score set by RAPS (official pass mark not publicly published) |
| Real Exam Qty: | Approx. 180 (divided into two parts) |
| Exam Format: | Multiple choice, Computer-based |
| Related Certifications: | RAC-Devices RAC-Drugs |
| Exam Price: | Fees vary by testing window and membership status (typically higher for non-members) |
| Available Languages: | English |
| Exam Duration: | Approx. 210 (3.5 hours) |
| Sample Questions: |  |
| Exam Way: | Computer-based testing at Pearson VUE centers or online proctored |
| Pre Condition: | Typically at least three years of regulatory affairs or related professional experience; specific prerequisites are determined by RAPS |
| Official Syllabus URL: | https://www.raps.org/certifications/rac/what-is-the-rac |
RAPS RAC-GS Exam Syllabus Topics:
| Section | Objectives |
|---|---|
| Product Lifecycle Management | - Pre-market requirements - Post-market compliance and pharmacovigilance |
| Global Regulatory Environment | - International regulatory frameworks - Global harmonization standards (e.g., ICH, WHO) |
| Regulatory Strategy and Submissions | - Strategic planning for global filings - Regulatory submission pathways |
| Country-Specific Regulations | - US regulatory requirements - EU regulatory requirements |
RAC-GS Exam FAQ: What Candidates Ask About RAPS Regulatory Affairs Certification (RAC) Global Scope
The RAC-GS exam, officially known as RAPS Regulatory Affairs Certification (RAC) Global Scope, is the RAPS test that leads to the RAC Regulatory Affairs Certification 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-Drugs, RAC-Devices.
The RAC-GS exam contains Approx. 180 (divided into two parts) questions, and you have Approx. 210 (3.5 hours) 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-GS exam is Scaled pass score set by RAPS (official pass mark not publicly published), and the official registration fee is Fees vary by testing window and membership status (typically higher for non-members). 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.
Typically at least three years of regulatory affairs or related professional experience; specific prerequisites are determined by RAPS
Entry requirements can change, so confirm the latest conditions on the official exam page: https://www.raps.org/certifications/rac/what-is-the-rac.
Yes. A free PDF demo of the RAPS Regulatory Affairs Certification (RAC) Global Scope 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-GS 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) Global Scope outline is organized into 4 domains. The first three are:
- Product Lifecycle Management
- Regulatory Strategy and Submissions
- Country-Specific Regulations
See the complete exam topics section above for the full outline and the weighting of every domain.
RAPS Regulatory Affairs Certification (RAC) Global Scope 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
At a recent scientific meeting,Company Y had two booths:
At one booth,Company Y provided brochures on a completed Phase II study.
In an adjacent booth, Company Y's sales professionals were promoting one of Company Y's marketed products.
A regulatory affairs-professional at Company X sends a letter to a counterpart at Company Y requesting that Company Y stop this practice in the future and demanding a formal response to the letter. How should the regulatory affairs professional at Company Y BEST respond?
A. Inform the local regulatory authority of the letter and discuss how to respond.
B. Inform the legal department of the letter and discuss how to respond.
C. Acknowledge receipt of the letter in a written response but do nothing further.
D. Inform Company X that it has no right to send such a letter and do nothing further.
Question 3
Which of the following is the PRIMARY purpose of an audit report?
A. To carry out a complete review of product applications
B. To define how to prepare new product submissions
C. To train sales representatives
D. Todocument compliance history
Question 4
Which of the following is NOT required to be included in a marketing application?
A. Quality, safety, and efficacy Information
B. Evidence of fee payment
C. Administrative forms
D. Final printed label
Question 5
An inspection of a manufacturing site determines that a number of manufacturing changes have been implemented without obtaining the necessary regulatory clearance. Which of the following actions should the regulatory affairs professional complete FIRST?
A. Assess the impact of the changes.
B. Establish validation procedures.
C. Review the stability data for the changes.
D. Stop product manufacturing.
Solutions:
| Question 1 Answer: B | Question 2 Answer: A,B | Question 3 Answer: D | Question 4 Answer: B | Question 5 Answer: A,D |
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