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RAPS RAC-GS : Regulatory Affairs Certification (RAC) Global Scope

Exam Code: RAC-GS

Exam Name: Regulatory Affairs Certification (RAC) Global Scope

Updated: Sep 11, 2026

Q & A: 100 Questions and Answers

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Passing Score, Duration, No of question, languages, Format of the RAPS RAC-GS Certification Exam

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  • No. of questions: 100
  • Exam Format: MCQs
  • Languages: English
  • Passing score: 65%
  • Time Duration: 120 Minutes

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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:

SectionObjectives
Global Regulatory Environment- International regulatory frameworks
- Global harmonization standards (e.g., ICH, WHO)
Country-Specific Regulations- EU regulatory requirements
- US regulatory requirements
Product Lifecycle Management- Pre-market requirements
- Post-market compliance and pharmacovigilance
Regulatory Strategy and Submissions- Strategic planning for global filings
- Regulatory submission pathways

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