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RAPS RAC-GS Exam Overview:
| Certification Vendor: | Regulatory Affairs Professionals Society (RAPS) |
|---|---|
| Exam Name: | Regulatory Affairs Certification (RAC) Global Scope |
| Exam Number: | RAC-GS |
| Related Certifications: | RAC-Devices RAC-Drugs |
| Available Languages: | English |
| Passing Score: | Scaled pass score set by RAPS (official pass mark not publicly published) |
| Exam Duration: | Approx. 210 (3.5 hours) |
| Exam Format: | Multiple choice, Computer-based |
| Exam Price: | Fees vary by testing window and membership status (typically higher for non-members) |
| Real Exam Qty: | Approx. 180 (divided into two parts) |
| 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 |
|---|---|
| Regulatory Strategy and Submissions | - Strategic planning for global filings - Regulatory submission pathways |
| Product Lifecycle Management | - Post-market compliance and pharmacovigilance - Pre-market requirements |
| Country-Specific Regulations | - EU regulatory requirements - US regulatory requirements |
| Global Regulatory Environment | - Global harmonization standards (e.g., ICH, WHO) - International regulatory frameworks |
Everything About the RAC-GS Exam and Our Materials
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Currently, the RAC-GS exam requires a passing score of Scaled pass score set by RAPS (official pass mark not publicly published) and carries a registration fee of Fees vary by testing window and membership status (typically higher for non-members). RAPS can revise either figure, so confirm both on the official site before you schedule.
Because every step is built to save time. The RAC-GS bank is carefully made — expert-verified answers across the RAPS Regulatory Affairs Certification (RAC) Global Scope objectives, organized for efficient study rather than endless reading. Delivery is instant upon payment, updates are free for 365 days and arrive by email automatically, and our customer service team is online 24 hours to give fast, precise replies whenever a question about the materials comes up. Efficiency is the design goal, from first click to exam day.
The RAPS Regulatory Affairs Certification (RAC) Global Scope blueprint is structured around these main domains:
- Regulatory Strategy and Submissions
- Product Lifecycle Management
- Country-Specific Regulations
Further domains complete the official outline; the question bank spans every one.
Per the latest exam information, the RAC-GS exam includes Approx. 180 (divided into two parts) questions and allows Approx. 210 (3.5 hours) minutes. Rehearsing under the same limit at home removes one more unknown from exam day.
Upon successful payment, our system automatically emails the product to your mailbox — typically within about a minute — with an instant download link on screen, so you can start studying right away. If nothing arrives within two hours, check your spam folder and contact our 24-hour support team. Installations are unlimited, and your purchase includes 365 days of free updates delivered by email, plus a 50% renewal discount afterward.
RAPS lists these prerequisites for the RAPS Regulatory Affairs Certification (RAC) Global Scope: Typically at least three years of regulatory affairs or related professional experience; specific prerequisites are determined by RAPS.
Confirm the current requirements on the official certification page before registering.
RAPS Regulatory Affairs Certification (RAC) Global Scope Sample Questions:
In the process of obtaining a product approval, a regulatory affairs professional discovers that the product does not meet one of the specific technical requirements of the regulation.
However, competitors with substantially similar products have claimed compliance with the requirement and received approval. Which action should the regulatory affairs professional take FIRST?
- A. Inform the regulatory authority that such a requirement is not applicable to the product.
- B. Inform the internal departments to redesign the product to comply with this requirement.
- C. Notify senior management that the product cannot be registered.
- D. Discuss with the regulatory apriority and attempt to reach an acceptable solution.
Correct Answer: D 🗳️
A company establishes a new medical device indication for its consumer disposable products. The regulatory affairs professional is asked to give a 30-minute training session on these products to sales representatives. Which of the following subjects is the MOST important to discuss?
- A. Labeling
- B. Safety-related reporting
- C. Regulatory application summary
- D. Risk management process
Correct Answer: A 🗳️
According to the GHTF, which of the following is NOT an exemption rule when evaluating the decision to report an adverse event?
- A. Adverse event caused by patient conditions
- B. Malfunction occurring before the end of service life of the medical device
- C. Malfunction protection operated correctly
- D. Deficiency of a device found by the user prior to patient use
Correct Answer: A,B 🗳️
The regulatory authority contacts the regulatory affairs professional regarding a complaint about a drug produced by the company. A consumer reported to the regulatory authority that the tablets have a slightly different color and break easily.
Which of the following actions should the regulatory affairs professional take?
- A. Respond to the regulatory authority that the company will provide copies of the relevant QCrecords for batch release.
- B. Ask that the regulatory authority provide the batch number printed on the packaging of the affected product.
- C. Respond to the regulatory authority that the product subject to the complaint is most likely acounterfeit product.
- D. Ask that the regulatory authority provide the actual product subject to the complaint.
Correct Answer: B 🗳️
The regulatory authority in Country X issued a request for a mandatory product recall in Country X due to serious injuries to patients. This product also is distributed in Country Y.
What should the regulatory affairs professional of the product's manufacturer FIRST do in Country Y?
- A. Review alt distribution records and complaints reported in Country Y.
- B. Initiate a mandatory recall of the product in Country Y.
- C. Prepare the legal team in Country Y for possible litigations.
- D. Draft a formal letter to customers in Country Y about this recall.
Correct Answer: A 🗳️
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