RAPS RAC-US : Regulatory Affairs Certification (RAC) US
- Exam Code: RAC-US
- Exam Name: Regulatory Affairs Certification (RAC) US
- Updated: Aug 06, 2026
- Q & A: 100 Questions and Answers
About RAPS RAC-US Exam
There are the topics covered by the RAPS RAC-US Certification Exam:
RAC-US exam dumps cover the following topics of the RAPS RAC-US Certification Exam:
- Pharmaceutical Regulations: 40%
- Medical Devices Regulations: 25%
- Medical Device Risk Management: 10%
- Drug Safety: 25%
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Following is the prerequisite for the RAPS RAC-US Certification Exam:
- You must be a member of RAPS, the Regulatory Affairs Professionals Society
- You should have a Bachelor's degree or higher
- You must have 3 to 5 years of experience in regulatory affairs.
RAPS RAC-US Exam Syllabus Topics:
| Section | Weight | Objectives |
|---|---|---|
| Topic 1: Strategic Planning | 24% | - US regulatory environment and framework - Product lifecycle strategy - Risk management and quality systems - Regulatory pathways and marketing authorization |
| Topic 2: Development and Pre-Market | 28% | - Design controls and technical documentation - CMC and manufacturing requirements - Labeling and advertising regulations - Clinical trials and non-clinical studies |
| Topic 3: Submissions and Regulatory Interactions | 24% | - Modifications, supplements, and variations - eCTD and electronic submission formats - Regulatory intelligence and planning - FDA review processes and communications |
| Topic 4: Post-Market and Compliance | 24% | - Compliance and continuous improvement - Reporting obligations and adverse events - Post-marketing surveillance and pharmacovigilance - Inspections, audits, and enforcement actions |
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