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Updated: Jul 23, 2026
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RAPS RAC-US (Regulatory Affairs Certification US) exam is a comprehensive certification exam designed for regulatory professionals who are looking to advance their careers in the field of regulatory affairs. RAC-US exam is administered by the Regulatory Affairs Professionals Society (RAPS), which is a leading global organization that represents regulatory professionals in the healthcare industry. The RAC-US certification is considered to be the gold standard for regulatory professionals in the United States.
The salary of a RAPS RAC-US Certified professional:
The salary of a RAPS RAC-US certified professional varies according to their designation and their employer. According to the salary comparison chart by sector, it is revealed that the average salary of a RAPS RAC-US certified professional is $85,000 per year. A RAPS RAC-US certified professional who passed the exam with the assistance of the RAC-US exam dumps can earn more than an uncertified one. Here is the list of the average salary of the RAPS RAC-US Certified professional:
- In the United Kingdom: 75,000 GBP
- In the United States: 85,000 USD
- In India: 70,000 INR
- In Canada: 95,000 CAD
RAPS RAC-US Exam Overview:
| Certification Vendor: | Regulatory Affairs Professionals Society (RAPS) |
| Exam Name: | Regulatory Affairs Certification (RAC) United States |
| Exam Number: | RAC-US |
| Exam Duration: | 120 minutes |
| Real Exam Qty: | 100 |
| Related Certifications: | RAC-EU RAC-Drugs RAC-Devices RAC-Global |
| Exam Price: | Member: $605 USD; Non-Member: $760 USD (2026 rates) |
| Passing Score: | Scaled score 70 (range 0–99) |
| Certificate Validity Period: | 3 years (requires recertification) |
| Available Languages: | English |
| Exam Format: | Computer-based, Multiple-choice, Recall, Application, Analysis |
| Recommended Training: | RAC-US Candidate Guide RAPS Official RAC Preparation Resources |
| 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 |
The RAC-US certification exam consists of four different modules, including US Regulations, Biologics and Pharmaceuticals, Medical Devices, and International Regulations. Each module is designed to test a candidate’s knowledge of the specific regulations and guidelines that govern that particular area of the healthcare industry. In order to pass the RAC-US exam, candidates must demonstrate a thorough understanding of the regulatory landscape and must be able to apply that knowledge to real-world scenarios. Successful completion of the RAC-US exam is an important milestone for regulatory affairs professionals, as it demonstrates a commitment to professional development and a dedication to excellence in the field.
The Regulatory Affairs Certification (RAC) US is an exam that is designed for regulatory professionals who want to validate their knowledge and expertise in the regulatory field. RAC-US exam is offered by the Regulatory Affairs Professionals Society (RAPS), an international organization that is dedicated to promoting the regulatory profession and advancing the regulatory industry. The RAC-US certification is recognized globally and is highly valued by employers in the regulatory field.
RAPS RAC-US Exam Syllabus Topics:
| Section | Weight | Objectives |
|---|---|---|
| Post-Market and Compliance | 24% | - Inspections, audits, and enforcement actions - Compliance and continuous improvement - Reporting obligations and adverse events - Post-marketing surveillance and pharmacovigilance |
| Submissions and Regulatory Interactions | 24% | - Modifications, supplements, and variations - FDA review processes and communications - Regulatory intelligence and planning - eCTD and electronic submission formats |
| Development and Pre-Market | 28% | - Clinical trials and non-clinical studies - Design controls and technical documentation - Labeling and advertising regulations - CMC and manufacturing requirements |
| Strategic Planning | 24% | - US regulatory environment and framework - Product lifecycle strategy - Regulatory pathways and marketing authorization - Risk management and quality systems |
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