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A bad result on the RAC-GS exam costs the fee, the wait, and the confidence. The RAPS Regulatory Affairs Certification (RAC) Global Scope practice set from Exams4sures — 100 questions — exists so your first result is your only result.

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
Exam Price:$605 (RAPS Member), $760 (Non-Member) - 2026 rates
Passing Score:70%
Certificate Validity Period:3 years
Exam Duration:210 minutes
Real Exam Qty:150-180
Available Languages:English
Related Certifications:RAC-Drugs
RAC-Devices
Exam Format:Recall, Application, Computer-Based, Multiple Choice, Analysis
Recommended Training:RAPS Online University
RAPS Fundamentals Textbooks
Exam Registration:RAPS Official Application
Pearson VUE Scheduling
Sample Questions: DOWNLOAD DEMO
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:

SectionWeightObjectives
Topic 1: Global Regulatory Environment & Strategy35%- Regulatory Strategy & Planning
  • 1. Regulatory Intelligence & Risk Management
    • 2. Global Market Access Strategy
      - International Regulatory Frameworks
      • 1. ICH, WHO, IMDRF, ISO Guidelines
        • 2. Regional Regulatory Systems
          Topic 2: Regulatory Submissions & Approval20%- Review Process & Interactions
          • 1. Regulatory Authority Interactions
            • 2. Deficiencies & Response Management
              - Global Dossiers & Submission Formats
              • 1. CTD/eCTD Structure
                • 2. National & Regional Application Routes
                  Topic 3: Product Development & Lifecycle Management25%- Chemistry, Manufacturing & Controls
                  • 1. GMP Requirements
                    • 2. Quality Systems & Documentation
                      - Clinical Research & Trials
                      • 1. Global Clinical Submissions
                        • 2. GCP Compliance
                          Topic 4: Post-Market Compliance & Surveillance20%- Pharmacovigilance & Adverse Events
                          • 1. Risk Management Plans
                            • 2. Global Reporting Requirements
                              - Labeling, Advertising & Changes
                              • 1. Global Labeling Rules
                                • 2. Post-Approval Changes & Variations

                                  RAPS Regulatory Affairs Certification (RAC) Global Scope FAQ: Answers That Matter

                                  The official fee is $605 (RAPS Member), $760 (Non-Member) - 2026 rates per attempt, and the passing score is 70%. A failed attempt means paying the entire fee again — which makes the 100 practice questions from Exams4sures the cheaper rehearsal. Self-test until the pass mark feels routine, then book.

                                  Your files arrive fast: successful payment triggers an automatic email within a minute, with instant download access and no installation limits — our 24/7 customer assistance handles anything still missing after 2 hours. And failure isn't the end: take the corresponding RAC-GS exam within 60 days of purchase, and if you don't pass, submit a scanned enrollment slip plus the official Score Report PDF within 2 days of the exam for a full refund processed within 7 days. Exclusions: exams within 3 days of purchase, name mismatches between candidate and payer, and free or expired products. You can also choose to change to two other equal-value exam products free instead of the refund.

                                  The RAPS Regulatory Affairs Certification (RAC) Global Scope blueprint spans 4 domains — among them Post-Market Compliance & Surveillance (20%), Regulatory Submissions & Approval (20%), Product Development & Lifecycle Management (25%). Weightings are the vendor's way of saying where points concentrate, so budget your time accordingly. The full outline above details every subtopic.

                                  Yes — download the free trial before you buy and check the question quality yourself. Purchases include 365 days of free updates, and if your update period expires later, renew it at half price.

                                  Yes:

                                  Courses teach; questions test. After finishing any training, run the RAC-GS practice questions from Exams4sures to verify what actually stuck.

                                  Bachelor's degree + 3 years regulatory experience; Master's + 2 years; Doctorate + 1 year; RAPS membership recommended Since vendors revise eligibility rules, confirm the current requirements on the official exam page (official RAC-GS exam page) before registering.

                                  Registration goes through the vendor's official channels:

                                  The exam runs Computer-based testing at Pearson VUE centers or online remote proctoring, so choose the arrangement that suits you when booking.

                                  The RAPS Regulatory Affairs Certification (RAC) Global Scope is RAPS's official exam for the Regulatory Affairs Certification (RAC) Global Scope certification, at the Professional level. It tests real professional knowledge and experience — that's why it's considered difficult, and why the credential means something. It also connects to related credentials like RAC-Drugs, RAC-Devices.

                                  You'll get 210 minutes for 150-180 questions. Lack of time sinks more candidates than lack of knowledge — so build your pacing now: set a per-question budget, practice flagging hard items, and run full timed sessions in the Exams4sures engine until the clock feels like an ally.

                                  RAPS Regulatory Affairs Certification (RAC) Global Scope Sample Questions:

                                  Which of the following changes to a drug product is MOST likely to be implemented without prior regulatory authority approval?

                                  • A. Deleting an ingredient of the drug product
                                  • B. Deleting a drug substance
                                  • C. Strengthening a precaution to the product labeling
                                  • D. Introducing a new analytical method
                                  Reveal Solution  Discussion  0

                                  Correct Answer: C  🗳️

                                  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.
                                  Reveal Solution  Discussion  0

                                  Correct Answer: B  🗳️

                                  During several monitoring visits, a clinical trial monitor identifies serious and repeated noncompliance on the part of the PI. What action should the sponsor take?

                                  • A. Increase the frequency of monitoring visits.
                                  • B. Send a letter of complaint to the Ethics Committee that approved the site.
                                  • C. Terminate the PI and inform the regulatory authorities.
                                  • D. Inform the institution that granted a medical license to the Pi.
                                  Reveal Solution  Discussion  0

                                  Correct Answer: C  🗳️

                                  In a distribution contract for high-risk medical devices, which of the following regulatory requirements is the MOST important for the distributor?

                                  • A. Written procedure for product traceability
                                  • B. Local reimbursement requirements
                                  • C. Service operation procedures
                                  • D. Training program for sales people
                                  Reveal Solution  Discussion  0

                                  Correct Answer: D  🗳️

                                  Why is it necessary to run supplemental safety pharmacology studies?

                                  • A. To comply with regulatory authority requirements related to clinical studies
                                  • B. To provide adverse reaction reports and the results of the statistical data to the regulatory authority
                                  • C. To substitute the utilization of GLP
                                  • D. To evaluate potential adverse pharmacodynamics effects not addressed by the core battery
                                  Reveal Solution  Discussion  0

                                  Correct Answer: D  🗳️

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