Speed matters on the RAC-GS exam, but so does consistency. Practicing with the software version's mock exams trains both: your answering pace quickens while your approach to each question type standardizes. CertkingdomPDF includes 100 practice questions for the RAPS Regulatory Affairs Certification (RAC) Global Scope exam to make that training thorough.
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 |
| Related Certifications: | RAC-Devices RAC-Drugs |
| Real Exam Qty: | 150-180 |
| Passing Score: | 70% |
| Exam Duration: | 210 minutes |
| Exam Price: | $605 (RAPS Member), $760 (Non-Member) - 2026 rates |
| Certificate Validity Period: | 3 years |
| Available Languages: | English |
| Exam Format: | Multiple Choice, Analysis, Computer-Based, Recall, Application |
| Recommended Training: | RAPS Online University RAPS Fundamentals Textbooks |
| Exam Registration: | Pearson VUE Scheduling RAPS Official Application |
| Sample Questions: |  |
| 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: Product Development & Lifecycle Management | 25% | - Chemistry, Manufacturing & Controls
|
| Topic 2: Global Regulatory Environment & Strategy | 35% | - Regulatory Strategy & Planning
|
| Topic 3: Post-Market Compliance & Surveillance | 20% | - Pharmacovigilance & Adverse Events
|
| Topic 4: Regulatory Submissions & Approval | 20% | - Global Dossiers & Submission Formats
|
RAC-GS Exam FAQ: Preparation Without the Pressure
Yes — true gold fears no fire, and our materials welcome the test. The free demo is cut directly from the real RAPS Regulatory Affairs Certification (RAC) Global Scope question bank, so you get a genuine preview of the content, plus a look at what the software version looks like after opening and how it is used. All demos at CertkingdomPDF are free of charge; download, examine, and decide about the RAC-GS exam package only when your questions are answered.
Registration is available through the official channels below:
Booking a realistic date — one that leaves room for several mock exam sessions — turns exam pressure into a structured countdown.
The RAC-GS exam requires 70% to pass, and registration costs $605 (RAPS Member), $760 (Non-Member) - 2026 rates. Since the fee applies to every attempt, candidates who rehearse thoroughly with mock exams before booking tend to make the smarter investment.
According to the official outline, the RAC-GS exam covers weighted domains including:
- Post-Market Compliance & Surveillance (20%)
- Global Regulatory Environment & Strategy (35%)
- Regulatory Submissions & Approval (20%)
The RAPS Regulatory Affairs Certification (RAC) Global Scope practice questions at CertkingdomPDF map onto these same objectives, so mock exam sessions in the software version exercise exactly the areas the real exam tests.
RAPS recommends the following training options:
Combine official courses with regular mock exams, and you cover both the knowledge side and the performance side of preparation.
The RAC-GS exam is the official test behind the RAPS Regulatory Affairs Certification (RAC) Global Scope certification from RAPS, and for many working professionals it ranks among the most essential exams of their career. It measures whether you can apply the published objectives in practical scenarios — which is precisely why rehearsing under realistic mock exam conditions, not just reading, makes such a difference to both confidence and results.
Bachelor's degree + 3 years regulatory experience; Master's + 2 years; Doctorate + 1 year; RAPS membership recommended
Practice tests mean a lot when an exam matters. The software version of the RAPS Regulatory Affairs Certification (RAC) Global Scope materials provides mock exams that let you accumulate real experience: each session builds familiarity with question flow and timing, which relieves stress, and at the same time increases your answering speed and the standardization of your responses. By the day of the real RAC-GS exam, you are not facing something new — you are repeating something practiced.
The RAC-GS exam includes 150-180 questions and allows 210 minutes minutes. That is limited time per question — mock exams under the same cap are the most direct way to build the pace you will need.
RAPS Regulatory Affairs Certification (RAC) Global Scope Sample Questions:
Which term does NOT describe the same concept as the others?
- A. Monoclonal antibody
- B. Subsequent entry biologics
- C. Follow-on protein products
- D. Biosimilars
Correct Answer: A 🗳️
During routine surveillance, a regulatory authority sent a company the following communication: "Hepatotoxicity and suicidal behavior were identified as potential safety issues for the company's product. The regulatory authority is evaluating these issues to determine the need for any regulatory action." Which action would be the most appropriate FIRST step for the company to take?
- A. Repeat the Hepatotoxicity tests and send the results to the regulatory authority.
- B. Contact the regulatory authority to discuss its findings.
- C. Contact the regulatory authority to argue that its conclusions are wrong.
- D. Wait for the regulatory authority's final publication on its findings.
Correct Answer: B 🗳️
A company is currently marketing an implantable orthopedic medical device. The R&D department is planning to change the material used for the implant. The R&D department states that the change does not impact the safety and effectiveness of the product.
What action should the regulatory affairs professional take FIRST?
- A. Write a memo to file since the change does not impact product safety and effectiveness.
- B. Review the content of change and supporting data for the equivalency with the current material.
- C. Prepare regulatory submissions that detail the medical device's change in materials.
- D. No action is needed in this situation.
Correct Answer: B 🗳️
As part of the regulatory strategy for companies intending to manufacture a psychotropic product, which of the following approvals should be received FIRST?
- A. Import license
- B. Export license
- C. Product license
- D. Site license
Correct Answer: D 🗳️
During a regulatory authority inspection of a manufacturing site, the inspector observes that one of the medicinal products manufactured at the site is not GMP compliant. The product Is distributed globally.
Which of the following is the most appropriate action to take FIRST?
- A. Notify the global regulatory authorities.
- B. Withdraw the affected product from the markets.
- C. Assess the potential safety risk.
- D. Send a "Dear Dr." letter to customers.
Correct Answer: A 🗳️
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