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Download RAPS : RAC-GS Questions & Answers as PDF & Test Software

Last Updated: Sep 19, 2026

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Everyone studies differently, which is why TestSimulate offers RAPS Regulatory Affairs Certification (RAC) Global Scope preparation in three formats: a printable PDF, a desktop test engine, and an online test engine. Whichever you choose, you work with the same 100 practice questions built around the RAC-GS exam.

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

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

                                  Everything Candidates Ask About RAPS Regulatory Affairs Certification (RAC) Global Scope

                                  The RAC-GS exam, officially titled Regulatory Affairs Certification (RAC) Global Scope, is the qualifying exam for the Regulatory Affairs Certification (RAC) Global Scope certification, which sits at the Professional level. Earning it shows employers that you have the skills the credential stands for, and it is a solid step forward on a RAPS career path. It also connects to RAC-Drugs, RAC-Devices, so the effort you put in now keeps paying off as you advance.

                                  The RAC-GS exam gives you 150-180 questions to complete within 210 minutes. Do the math before exam day: divide the total time by the question count to set a steady per-question pace, and flag any item that stalls you so you can return to it after securing the easier points. The most reliable way to build that rhythm is a full timed practice test under the same limit, which is exactly what TestSimulate's test engines are designed for.

                                  The passing score for RAPS Regulatory Affairs Certification (RAC) Global Scope is 70%, and the official registration fee is $605 (RAPS Member), $760 (Non-Member) - 2026 rates. Keep in mind that a retake means paying that fee again in full, which makes an honest self-check worthwhile: before you book, sit a timed practice test and make sure you are consistently scoring above the passing line with some margin to spare.

                                  According to the official requirements: Bachelor's degree + 3 years regulatory experience; Master's + 2 years; Doctorate + 1 year; RAPS membership recommended. Eligibility rules do change from time to time, so confirm the current details on the official exam page before you register.

                                  Registration for the RAC-GS exam is handled through the official channels below:

                                  The exam is delivered in the following format: Computer-based testing at Pearson VUE centers or online remote proctoring. Pick a date that leaves room for at least one full timed practice test beforehand.

                                  RAPS recommends the following official training options for candidates preparing for RAPS Regulatory Affairs Certification (RAC) Global Scope:

                                  Courses build the foundation, but they work best alongside question practice. That is where TestSimulate comes in: the 100 practice questions in our RAC-GS package let you rehearse the exam format at your own pace and see exactly where you stand.

                                  Yes — TestSimulate offers a free PDF demo of the RAPS Regulatory Affairs Certification (RAC) Global Scope material, so you can review the question style and answer quality before you spend anything. After purchase, you also receive 365 days of free updates, and if your product expires you can extend the update service at a 50% discount from your member zone.

                                  If you take the corresponding exam within 60 days of your purchase and do not pass, you are covered by the 100% Money Back Guarantee under clear conditions. To claim a full refund, submit a scan of your exam enrollment slip and your official Score Report PDF within two days of the exam; requests are processed within seven days. Note that sitting the exam within three days of purchase is not eligible, purchases that were never followed by an exam sitting do not qualify, free materials and expired orders are excluded, and the candidate name must match the payer name. Prefer an exchange instead? You can swap your product for two free exam packages of equal value and keep your update service. Delivery is immediate: your RAC-GS material is ready for instant download and is also emailed to you within one minute of payment — contact customer service if nothing arrives within two hours. There is no limit on the number of computers you can install it on.

                                  The current RAPS Regulatory Affairs Certification (RAC) Global Scope syllabus is organized into 4 exam domains. The first three are:

                                  • Product Development & Lifecycle Management (25%)
                                  • Post-Market Compliance & Surveillance (20%)
                                  • Regulatory Submissions & Approval (20%)

                                  For the full domain and subtopic breakdown, see the Exam Topics section above — that is the outline your TestSimulate practice questions are mapped to.

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

                                  Question #1

                                  Company X and Company Y both have products for the treatment of rare genetic diseases. Company X would like to acquire Company Y but does not know enough about Company Y to make an offer.
                                  What is the MOST appropriate approach that Company X should take to acquire more information about Company Y?

                                  • A. Enter into an agreement with Company Y to perform due diligence.
                                  • B. Request the needed information from the Board of Directors of Company Y.
                                  • C. Perform a thorough library search to gather detailed information on Company Y.
                                  • D. Recruit a professional to gather confidential intelligence on Company Y.
                                  Reveal Solution  Discussion  0

                                  Correct Answer: A  🗳️

                                  Question #2

                                  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. Withdraw the affected product from the markets.
                                  • B. Send a "Dear Dr." letter to customers.
                                  • C. Notify the global regulatory authorities.
                                  • D. Assess the potential safety risk.
                                  Reveal Solution  Discussion  0

                                  Correct Answer: C  🗳️

                                  Question #3

                                  A company is developing a line of products for which no ISO standard of performance is available. As a result, the company wishes to propose developing such a standard. Whom should the company contact in order to start the development of the new standard?

                                  • A. The ISO technical committee in charge of the area
                                  • B. The country's regulatory authority
                                  • C. The ISO Secretariat
                                  • D. The ISO national member body
                                  Reveal Solution  Discussion  0

                                  Correct Answer: B,D  🗳️

                                  Question #4

                                  A materials supplier informs a company that it intends to stop supplying a material critical to the manufacture of the company's products. What action should the company take FIRST?

                                  • A. Qualify another supplier and execute a supplier agreement.
                                  • B. Reformulate the products with a replacement material.
                                  • C. Review the company's existing Quality ManagementSystem
                                  • D. Complete a gap analysis to identify options.
                                  Reveal Solution  Discussion  0

                                  Correct Answer: A,D  🗳️

                                  Question #5

                                  Which of the following is an example of an acceptable statement for an advertisement of an approved arthritis medication?

                                  • A. "Product X is safe for arthritis and without side effects."
                                  • B. "Product X is effective in all patients with arthritis."
                                  • C. "Product X is effective for the treatment of arthritis."
                                  • D. "Product X is a guaranteed cure for arthritis."
                                  Reveal Solution  Discussion  0

                                  Correct Answer: C  🗳️

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