RAPS RAC-US Exam Information and Actual Questions

  • Exam Code/Number: RAC-US
  • Exam Name/Title: Regulatory Affairs Certification (RAC) US
  • Certification Provider: RAPS
  • Corresponding Certification: RAC Regulatory Affairs Certification
  • Exam Questions: 100
  • Updated On: Aug 19, 2026

RAC-US
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RAPS
RAC-US Exam
Regulatory Affairs Certification (RAC) US

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All the information you need to pass RAPS Regulatory Affairs Certification (RAC) US RAC-US exam and free practice exam verified by ExamDiscuss exam experts.

To be eligible to take the RAC-US exam, candidates must have a minimum of 3 years of regulatory experience in the healthcare industry. Candidates must also meet certain educational requirements, which may vary depending on their level of experience. RAC-US exam is open to individuals from all countries, and there are no restrictions on nationality or location.

The Regulatory Affairs Certification (RAC) US exam is a professional certification exam designed for individuals in the regulatory affairs field. RAC-US exam evaluates a candidate's knowledge, skills, and abilities in regulatory affairs in the United States. The RAC-US exam is one of the most prestigious and sought-after certifications in the regulatory affairs industry, and passing it demonstrates a high level of expertise and knowledge in this field.

The Regulatory Affairs Certification (RAC) US exam is a professional certification program that is designed to validate the skills and knowledge of regulatory affairs professionals in the United States. RAC-US exam is administered by the Regulatory Affairs Professionals Society (RAPS), which is the largest global organization for regulatory affairs and healthcare product professionals. The RAC-US exam is a rigorous and comprehensive assessment that covers a wide range of topics related to regulatory affairs, including pharmaceuticals, medical devices, biologics, and veterinary products.

RAPS RAC-US Exam Overview:

Certification Vendor:Regulatory Affairs Professionals Society (RAPS)
Exam Name:Regulatory Affairs Certification (RAC) United States
Exam Number:RAC-US
Passing Score:Scaled score 70 (range 0–99)
Available Languages:English
Exam Duration:120 minutes
Related Certifications:RAC-EU
RAC-Drugs
RAC-Devices
RAC-Global
Certificate Validity Period:3 years (requires recertification)
Exam Format:Computer-based, Multiple-choice, Recall, Application, Analysis
Real Exam Qty:100
Exam Price:Member: $605 USD; Non-Member: $760 USD (2026 rates)
Recommended Training:RAPS Official RAC Preparation Resources
RAC-US Candidate Guide
Exam Registration:RAPS RAC Application Portal
Sample Questions:RAPS RAC-US Sample Questions
Exam Way:Online remote proctored or in-person at authorized testing centers
Pre Condition:Bachelor's + 3 years experience; Master's + 2 years; Doctorate + 1 year; or 10+ years regulatory experience
Official Syllabus URL:https://www.raps.org/certifications/rac/rac-us

RAPS RAC-US Exam Syllabus Topics:

SectionWeightObjectives
Submissions and Regulatory Interactions24%- eCTD and electronic submission formats
- FDA review processes and communications
- Modifications, supplements, and variations
- Regulatory intelligence and planning
Post-Market and Compliance24%- Post-marketing surveillance and pharmacovigilance
- Reporting obligations and adverse events
- Compliance and continuous improvement
- Inspections, audits, and enforcement actions
Development and Pre-Market28%- CMC and manufacturing requirements
- Labeling and advertising regulations
- Design controls and technical documentation
- Clinical trials and non-clinical studies
Strategic Planning24%- Regulatory pathways and marketing authorization
- US regulatory environment and framework
- Product lifecycle strategy
- Risk management and quality systems


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