- Exam Code: RAC-GS
- Exam Name: Regulatory Affairs Certification (RAC) Global Scope
- Updated: Aug 22, 2026
- Q & A: 100 Questions and Answers
The purpose of the RAC-GS Certification Exam is to test the knowledge, skills, and abilities of candidates for the certification. The RAC-GS Certification Exam is intended to be used by candidates as a credential that would demonstrate their knowledge, skills, and abilities and be valid evidence of their competence in Regulatory Affairs. It is also intended to be used by candidates to demonstrate their knowledge, skills, and abilities to prospective employers, academic institutions, and regulatory agencies. RAC-GS exam dumps will guide you well in getting certified for this exam. Multimedia presentations that demonstrate the candidate's knowledge, skills, and abilities are also expected from candidates. Glory be to RAPS for offering this Certification Exam. Transition to RAC-GS Certification Exam has been an excellent idea for all R&D personnel, whether they are new to Regulatory Affairs or have some experience in Regulatory Affairs. The foreign establishment is another category that can benefit from RAC-GS Certification Exam.
In this era of Globalization and the need for global harmonization in various domains such as Health, Financial Services, medicinal Devices, Pharmaceuticals, Public Health, and Bio-Technology, it has become important for Regulatory Affairs Professionals to have the RAC-GS Certification Exam and show their knowledge, skills, and abilities in various areas of Regulatory Affairs. This Certification Exam will enable Regulatory Affairs Professionals to identify themselves and their professional skills in various areas of regulatory affairs. The RAC-GS exam dumps are a great tool to help you get certified for this exam. Electronic slideshows or audiovisual materials are also needed from candidates. Embedded music is prohibited. Candidates must submit an original and unmodified picture of themselves with their official credentials, a copy of their passport, and a brief biography.
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| Section | Objectives |
|---|---|
| Topic 1: Post-Market Surveillance | - Lifecycle management and variations - Pharmacovigilance and safety reporting |
| Topic 2: Regulatory Strategy and Compliance | - Quality systems and inspections - Regulatory strategy development |
| Topic 3: Regulatory Submissions | - Dossier preparation (eCTD and regional formats) - Global marketing authorization applications |
| Topic 4: Drug Development Lifecycle | - Preclinical and clinical development stages - Clinical trial design and regulatory requirements |
| Topic 5: Regulatory Foundations | - Global regulatory systems and authorities - Regulatory ethics and compliance principles |
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