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Last Updated: Sep 11, 2026

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  • Career Growth and more salary: The RAPS RAC-GS certification will enhance your career growth and increase your salary. It also helps you to increase your chances of landing a job in Regulatory Affairs. The certification also acts as an advantage when applying for jobs.

What is the Prerequisite for taking the RAPS RAC-GS Certification Exam?

The candidates are required to have at least a bachelor's degree or equivalent and two years of relevant experience in the healthcare product sector. They are also needed to have at least one year of professional experience in Regulatory Affairs. Premarket approval required by the regulatory agency is also needed for those candidates who wish to take the RAC-GS Certification Exam.

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RAPS RAC-GS Exam Syllabus Topics:

SectionWeightObjectives
Topic 1: Global Regulatory Environment & Strategy35%- International Regulatory Frameworks
  • 1. ICH, WHO, IMDRF, ISO Guidelines
    • 2. Regional Regulatory Systems
      - Regulatory Strategy & Planning
      • 1. Global Market Access Strategy
        • 2. Regulatory Intelligence & Risk Management
          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: 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
                          Topic 4: Product Development & Lifecycle Management25%- Clinical Research & Trials
                          • 1. GCP Compliance
                            • 2. Global Clinical Submissions
                              - Chemistry, Manufacturing & Controls
                              • 1. GMP Requirements
                                • 2. Quality Systems & Documentation
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