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Reading questions is one thing; sitting a timed exam is another. The Fast2test desktop and online test engines recreate the pace and pressure of the RAPS Regulatory Affairs Certification (RAC) Global Scope testing environment, so RAC-GS exam day feels like just another practice session.

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
Available Languages:English
Passing Score:70%
Exam Format:Multiple Choice, Computer-Based, Application, Analysis, Recall
Exam Price:$605 (RAPS Member), $760 (Non-Member) - 2026 rates
Certificate Validity Period:3 years
Real Exam Qty:150-180
Exam Duration:210 minutes
Recommended Training:RAPS Online University
RAPS Fundamentals Textbooks
Exam Registration:Pearson VUE Scheduling
RAPS Official Application
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
Topic 1: Regulatory Submissions & Approval20%- Review Process & Interactions
  • 1. Deficiencies & Response Management
    • 2. Regulatory Authority Interactions
      - Global Dossiers & Submission Formats
      • 1. National & Regional Application Routes
        • 2. CTD/eCTD Structure
          Topic 2: Product Development & Lifecycle Management25%- Clinical Research & Trials
          • 1. Global Clinical Submissions
            • 2. GCP Compliance
              - Chemistry, Manufacturing & Controls
              • 1. Quality Systems & Documentation
                • 2. GMP Requirements
                  Topic 3: Global Regulatory Environment & Strategy35%- International Regulatory Frameworks
                  • 1. Regional Regulatory Systems
                    • 2. ICH, WHO, IMDRF, ISO Guidelines
                      - Regulatory Strategy & Planning
                      • 1. Regulatory Intelligence & Risk Management
                        • 2. Global Market Access Strategy
                          Topic 4: Post-Market Compliance & Surveillance20%- Labeling, Advertising & Changes
                          • 1. Global Labeling Rules
                            • 2. Post-Approval Changes & Variations
                              - Pharmacovigilance & Adverse Events
                              • 1. Risk Management Plans
                                • 2. Global Reporting Requirements

                                  RAPS RAC-GS FAQs: What Every Candidate Asks

                                  The RAC-GS exam, officially titled Regulatory Affairs Certification (RAC) Global Scope, is the qualifying test for the Regulatory Affairs Certification (RAC) Global Scope certification from Regulatory Affairs Professionals Society (RAPS), a credential at the Professional level. Passing it proves you have the skills employers look for in certified professionals, and it can also support progress toward related credentials such as RAC-Drugs, RAC-Devices.

                                  The RAPS Regulatory Affairs Certification (RAC) Global Scope exam gives you 210 minutes to work through 150-180 questions. That is a steady pace with little room for second-guessing, so train yourself to read each question once, flag the difficult ones, and keep moving. Before exam day, sit at least two full timed sessions in the Fast2test test engine — when the clock feels familiar, it stops being a threat.

                                  You need 70% to pass, and the official registration fee is $605 (RAPS Member), $760 (Non-Member) - 2026 rates. Fall short and you pay that fee in full again for every retake, which makes solid preparation the cheaper option by far. Work through the Fast2test practice questions until you score comfortably above the passing mark, then book your seat.

                                  Bachelor's degree + 3 years regulatory experience; Master's + 2 years; Doctorate + 1 year; RAPS membership recommended Eligibility rules can change over time, so before you register, confirm the latest requirements on the official exam page: Regulatory Affairs Professionals Society (RAPS) RAC-GS exam overview.

                                  You can book your RAC-GS exam through any of these official registration channels:

                                  The exam is delivered as Computer-based testing at Pearson VUE centers or online remote proctoring, so you can pick the option that fits your schedule when you book.

                                  Regulatory Affairs Professionals Society (RAPS) recommends the following training for RAPS Regulatory Affairs Certification (RAC) Global Scope candidates:

                                  Pair that training with the 100 practice questions from Fast2test and you can check your readiness topic by topic before exam day.

                                  Yes. Fast2test offers a free PDF demo for the RAPS Regulatory Affairs Certification (RAC) Global Scope exam so you can judge the quality of our questions and answers before paying anything. Every purchase also comes with 365 days of free updates, and once that period expires you can extend your update service at a 50% discount.

                                  Your purchase is protected by a 100% money-back guarantee. If you sit the corresponding RAC-GS exam within 60 days of buying and do not pass, send us a scan of your exam enrollment slip together with your official Score Report (PDF) within 2 days of the exam date — the candidate name must match the payer's name — and we will process your full refund within 7 days. Please note that exams taken within 3 days of purchase, materials downloaded without ever sitting the exam, free products, and expired orders are not covered. If you would rather not have a refund, you can exchange your order for two exam products of equal value, free of charge, and keep the update service on your original purchase.

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                                  The RAPS Regulatory Affairs Certification (RAC) Global Scope syllabus is organized into 4 domains. The main areas include Regulatory Submissions & Approval (20%), Product Development & Lifecycle Management (25%), and Post-Market Compliance & Surveillance (20%). Scroll up to the Exam Topics section above for the complete, current outline before you plan your study schedule.

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

                                  A global company is developing a sophisticated implantable medical device that is coated with antibiotics and biologics to enhance its efficacy. The product is marketed in Country X.
                                  where it is regulated as a medical device. The same product, without theantibiotics and biologics, is marketed as a medical device in Country Y.
                                  The company is proposing to start marketing the coated device in Country Y.
                                  Which regulatory approach should the company propose?

                                  • A. Submit the product for review as a pharmaceutical product in Country Y.
                                  • B. Submit the product as a medical device in Country Y as the product is already marketed in Country X as a medical device.
                                  • C. Apply for review of the additional part of the product as a pharmaceutical product in Country
                                  • D. E. Examine decisions made about similar products in Country Y to propose the classification ofthe product.
                                  Answer: C,D

                                  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.
                                  Answer: B

                                  A process is ultimately validated to ensure which of the following?

                                  • A. The process meets the quality system requirements.
                                  • B. The process consistently meets the desiredQuantity standards
                                  • C. The process consistently produces the desired results.
                                  • D. The process meets the regulatory requirements.
                                  Answer: C

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

                                  What are the MOST important elements that global regulatory agencies want to know before approving a new product for sale in their countries?

                                  • A. Quality and effectiveness
                                  • B. Safety and failure risk
                                  • C. Quality and failure risk
                                  • D. Safety and effectiveness
                                  Answer: D

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