Exam Name: Regulatory Affairs Certification (RAC) Global Scope
Certification Provider: RAPS
Corresponding Certification: RAC Regulatory Affairs Certification
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- Total Questions: 100
- Updated on: Sep 01, 2026
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RAPS RAC-GS Exam Overview:
| Certification Vendor: | Regulatory Affairs Professionals Society (RAPS) |
|---|---|
| Exam Name: | RAC Global Scope Examination (RAC-GS) |
| Exam Number: | RAC-GS |
| Related Certifications: | RAC Devices RAC US RAC Drugs |
| Available Languages: | English |
| Certificate Validity Period: | 3 years (recertification required) |
| Exam Format: | Computer-based multiple-choice exam |
| Recommended Training: | RAPS Learning Center |
| Exam Registration: | RAPS Certification Portal |
| Sample Questions: | RAPS RAC-GS Sample Questions |
| Exam Way: | Computer-based testing at authorized test centers or online proctored delivery (availability may vary by region) |
| Pre Condition: | No formal prerequisite required; typically recommended 3+ years of regulatory affairs experience or equivalent professional background. |
| Official Syllabus URL: | https://www.raps.org/certification |
RAPS RAC-GS Exam Syllabus Topics:
| Section | Objectives |
|---|---|
| Topic 1: Regulatory Foundations | - Global regulatory systems and authorities - Regulatory ethics and compliance principles |
| Topic 2: Post-Market Surveillance | - Lifecycle management and variations - Pharmacovigilance and safety reporting |
| Topic 3: Drug Development Lifecycle | - Preclinical and clinical development stages - Clinical trial design and regulatory requirements |
| Topic 4: Regulatory Submissions | - Global marketing authorization applications - Dossier preparation (eCTD and regional formats) |
| Topic 5: Regulatory Strategy and Compliance | - Quality systems and inspections - Regulatory strategy development |
RAC-GS Exam FAQ: What Candidates Ask About RAPS Regulatory Affairs Certification (RAC) Global Scope
The RAC-GS exam, officially titled Regulatory Affairs Certification (RAC) Global Scope, is the RAPS exam you pass to earn the Regulatory Affairs Certification (RAC) - Global Scope certification, a credential at the Professional level. Passing it confirms the skills defined in the official exam outline, and it is associated with related credentials such as RAC Drugs, RAC Devices, RAC US.
RAPS lists the following prerequisites or eligibility notes for the RAC-GS exam: No formal prerequisite required; typically recommended 3+ years of regulatory affairs experience or equivalent professional background.. Requirements can change over time, so confirm the details on the official exam page at RAPS's official site before you register.
You can register for the RAC-GS exam through the official channels below:
The exam is delivered in the following format: Computer-based testing at authorized test centers or online proctored delivery (availability may vary by region). Choose a date that leaves you enough time to work through the full 100-question practice set first.
RAPS recommends the following training resources for RAC-GS candidates:
Official courses build the theory, and the 100 practice questions from Fast2test help you turn that theory into exam-ready speed and accuracy.
Yes. Fast2test offers a free PDF demo of the RAC-GS material, so you can check the question style and answer quality before purchasing. Every purchase also includes 365 days of free updates, and if your product expires you can extend the update service at a 50% discount from your member zone.
Your purchase is protected by a 100% Money Back Guarantee with clear conditions: if you take the corresponding RAC-GS exam within 60 days of purchase and do not pass, you can apply for a full refund. The candidate name must match the payer name, and you need to submit a scanned exam enrollment slip together with the official Score Report PDF within 2 days of taking the exam; claims are processed within 7 days. Sitting the exam within 3 days of purchase, downloading without taking the exam, free materials, and expired orders are not covered. If you would rather not take a refund, you can exchange your order for two free exam products of equal value and keep the update service on your original purchase.
Delivery is instant: your download links are emailed within one minute of payment, and you can also download directly from the website. If nothing arrives within 2 hours, contact customer service and check your spam folder. There is no limit on how many computers you can install the material on.
The RAC-GS exam blueprint is divided into 5 domains, starting with Regulatory Foundations; Post-Market Surveillance; Regulatory Strategy and Compliance. For the complete domain-by-domain breakdown, see the Exam Topics section above — it lists every topic the current outline covers.
RAPS Regulatory Affairs Certification (RAC) Global Scope Sample Questions:
Question 1
A drug product presents degradation during the manufacturing process. In addition to the amount, what information should be provided FIRST in order to use API overage?
A. Formulation
B. Specification
C. Property
D. Justification
Question 2
According to ICH, what is the MAXIMUM amount of timein calendar days that anorganizationhas from the initial receipt of information to report serious and unexpected ADR of a marketed product to regulatory authorities?
A. 15
B. 10
C. 5
D. 3
Question 3
A regulatory affairs professional has submitted a package for regulatory review. According to the regulation, the regulatory authority will need to respond within 90 days of submission. If there is no response after the deadline, what is the BEST approach?
A. Contact the regulatory authority, ask for clarification about the delay, and provide answers to any outstanding questions.
B. Contact the company legal representative in order to begin legal proceedings to enforce the regulatory authority's response time.
C. Contact the local political representative and ask for intervention with the regulatory authority to obtain a decision regarding the submission.
D. Contact the regulatory authority, ask for clarification about the delay, and demand a decision be made regarding the submission.
Question 4
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. Contact the regulatory authority to argue that its conclusions are wrong.
B. Contact the regulatory authority to discuss its findings.
C. Repeat the Hepatotoxicity tests and send the results to the regulatory authority.
D. Wait for the regulatory authority's final publication on its findings.
Question 5
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. Prepare regulatory submissions that detail the medical device's change in materials.
B. Review the content of change and supporting data for the equivalency with the current material.
C. Write a memo to file since the change does not impact product safety and effectiveness.
D. No action is needed in this situation.
Solutions:
| Question 1 Answer: D | Question 2 Answer: A,B,C | Question 3 Answer: A | Question 4 Answer: B | Question 5 Answer: B |
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