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Access 100 expert-verified RAC-GS questions instantly through PDF, Desktop, or Online Test Engine formats. Actual4Labs is your dedicated partner for passing the RAPS Regulatory Affairs Certification (RAC) Global Scope exam on your first attempt in 2026.
| Certification Vendor: | Regulatory Affairs Professionals Society (RAPS) |
|---|---|
| Exam Name: | RAC Global Scope Examination (RAC-GS) |
| Exam Number: | RAC-GS |
| Certificate Validity Period: | 3 years (recertification required) |
| Available Languages: | English |
| Related Certifications: | RAC US RAC Drugs RAC Devices |
| Exam Format: | Computer-based multiple-choice exam |
| Recommended Training: | RAPS Learning Center |
| Exam Registration: | RAPS Certification Portal |
| Sample Questions: | DOWNLOAD DEMO |
| 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 |
| Section | Objectives |
|---|---|
| Topic 1: Post-Market Surveillance | - Lifecycle management and variations - Pharmacovigilance and safety reporting |
| Topic 2: Regulatory Strategy and Compliance | - Quality systems and inspections - Regulatory strategy development |
| Topic 3: Regulatory Foundations | - Global regulatory systems and authorities - Regulatory ethics and compliance principles |
| Topic 4: Regulatory Submissions | - Global marketing authorization applications - Dossier preparation (eCTD and regional formats) |
| Topic 5: Drug Development Lifecycle | - Clinical trial design and regulatory requirements - Preclinical and clinical development stages |
The RAC-GS exam is a core requirement for the Regulatory Affairs Certification (RAC) - Global Scope certification at the Professional level. Earning this validates your skills for credentials like RAC Drugs, RAC Devices, RAC US.
Candidate requirements include: No formal prerequisite required; typically recommended 3+ years of regulatory affairs experience or equivalent professional background.. Please verify all eligibility details on the official certification page before scheduling your appointment.
Registration is handled through official testing partners. The exam is delivered via Computer-based testing at authorized test centers or online proctored delivery (availability may vary by region). You can sign up here:
The vendor suggests following official learning paths to build a foundational understanding:
Once you complete your training, use the 100 practice questions from Actual4Labs to refine your exam readiness.
Absolutely. A free PDF demo is available for you to evaluate the quality of our questions. Once purchased, you receive 365 days of free updates. If your access expires, you can renew it at a 50% discount to keep your materials current.
Your RAC-GS practice materials are delivered instantly. You can download them right away, and a copy will be sent to your email within one minute (contact support if not received in 2 hours). You can install the software on an unlimited number of computers. We also offer a 100% Money Back Guarantee: if you fail the corresponding exam within 60 days of purchase, you can claim a full refund. To apply, submit your enrollment slip and official Score Report PDF within 2 days after taking the test (processing takes up to 7 days). Note: failures within 3 days of purchase, downloaded but unattempted exams, free materials, and expired orders are excluded. The payer's name must match the candidate's name. Alternatively, you can exchange your order for two free exams of equal value and keep the original product's updates.
The syllabus is divided into 5 main domains. Key areas include "Regulatory Foundations", "Drug Development Lifecycle", "Regulatory Strategy and Compliance". For a comprehensive breakdown of all measured skills, please review the complete exam outline table provided above.
Question 1
According to ICH, which of the following components of study information is NOT required in a clinical study report?
A. Randomization scheme and codes
B. ListoflECsorlRBs
C. Detailed CVofall investigators
D. Protocol and protocol amendments
Question 2
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. Ask that the regulatory authority provide the actual product subject to the complaint.
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 company will provide copies of the relevant QCrecords for batch release.
D. Respond to the regulatory authority that the product subject to the complaint is most likely acounterfeit product.
Question 3
The intermediate manufacturing process was changed during development of a pharmaceutical. The change may impact the API specification. Which functional area is responsible for the final approval of the change?
A. Regulatory
B. Quality
C. Analytical
D. Production
Question 4
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. Initiate a mandatory recall of the product in Country Y.
B. Review alt distribution records and complaints reported in Country Y.
C. Draft a formal letter to customers in Country Y about this recall.
D. Prepare the legal team in Country Y for possible litigations.
Question 5
Under which of the following circumstances would a regulatory authority require a more detailed premarket submission, a more rigorous audit, and/or the provision of more performance evaluation data than would normally apply to an IVD device of that risk class?
A. The manufacturer's experience level with the type of IVD medical device is limited.
B. Internationally recognized standards are available to cover the main aspects of the device and have been used by the manufacturer.
C. The device is an updated version of a compliant device from the same manufacturer and contains no substantive change.
D. The device incorporates well-established technology that is already present in the market.
Solutions:
| Question 1 Answer: C | Question 2 Answer: B | Question 3 Answer: A,B | Question 4 Answer: B | Question 5 Answer: A |
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