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Updated: Sep 07, 2026
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RAPS RAC-GS Certification Exam is an excellent opportunity for regulatory professionals who want to advance their careers and demonstrate their expertise in global regulatory affairs. It is a challenging exam that requires a deep understanding of the regulatory landscape across different regions, and passing the exam is a significant achievement that can enhance a candidate's professional credibility and career prospects.
RAPS RAC-GS exam covers a wide range of topics related to regulatory affairs, including regulatory strategies, submissions, compliance, and post-approval activities. RAC-GS exam is divided into four different modules, each of which focuses on a specific area of regulatory affairs. The modules include: Global Strategy and Governance, Product Development and Regulation, Regulatory Submissions and Approvals, and Post-Marketing Regulatory Activities.
RAPS RAC-GS Exam Overview:
| 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) |
| Exam Format: | Computer-based multiple-choice exam |
| Available Languages: | English |
| Related Certifications: | RAC Drugs RAC US RAC Devices |
| 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 |
|---|---|
| Regulatory Submissions | - Dossier preparation (eCTD and regional formats) - Global marketing authorization applications |
| Regulatory Foundations | - Global regulatory systems and authorities - Regulatory ethics and compliance principles |
| Regulatory Strategy and Compliance | - Quality systems and inspections - Regulatory strategy development |
| Post-Market Surveillance | - Pharmacovigilance and safety reporting - Lifecycle management and variations |
| Drug Development Lifecycle | - Preclinical and clinical development stages - Clinical trial design and regulatory requirements |
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