Exam Code: RAC-US
Exam Name: Regulatory Affairs Certification (RAC) US
Certification Provider: RAPS
Corresponding Certification: RAC Regulatory Affairs Certification

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Updated: Aug 02, 2026

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RAPS RAC-US Exam Overview:

Certification Vendor:	Regulatory Affairs Professionals Society (RAPS)
Exam Name:	Regulatory Affairs Certification (RAC) US
Exam Number:	RAC-US
Exam Price:	USD 605 (RAPS Member), USD 760 (Non-Member)
Available Languages:	English
Related Certifications:	RAC-Global RAC-EU RAC-Canada RCC
Exam Duration:	120 minutes
Real Exam Qty:	100
Passing Score:	Scaled score of 75
Certificate Validity Period:	3 years
Exam Format:	Computer-based, Multiple-choice, Recall, Application, Analysis
Sample Questions:	RAPS RAC-US Sample Questions
Exam Way:	Pearson VUE Test Center or Online Proctored Exam (OnVUE)
Pre Condition:	Bachelor's degree and 3 years regulatory experience; or Master's degree and 2 years regulatory experience; or Doctorate degree and 1 year regulatory experience.
Official Syllabus URL:	https://www.raps.org/certifications/rac

Here is the importance of the RAPS RAC-US Certification Exam:

Nowadays, the healthcare industry has undergone several changes. Regulatory agencies have been faced with a number of challenges which include an increase in the number of regulations, the rising cost of regulations, and the need to be more efficient and proactive in order to meet their goals. The RAC-US Certification can help healthcare regulatory professionals like you to prove that you are knowledgeable and competent in this rapidly changing and challenging environment. It is a great way to showcase your skills and show that you are a leader in the field. A free demo of the RAC-US exam dumps can help you to prepare for the real exam. The clinical trial is not required for the RAC-US Certification exam. Medication and medical device manufacturers can apply for registration on their own, the registration process for the RAC-US Exam is very simple and straightforward.

RAPS RAC-US Certification Exam covers a wide range of topics related to regulatory affairs, including regulatory strategy, product development, clinical trials, labeling and advertising, post-market surveillance, and international regulations. RAC-US exam is designed to be comprehensive, and is based on the RAPS RAC-US exam blueprint, which outlines the knowledge and skills required for certification.

Achieving the RAC-US certification demonstrates to employers and colleagues that an individual has a comprehensive understanding of the regulatory landscape and a commitment to professional development. Regulatory Affairs Certification (RAC) US certification can also lead to increased job opportunities and higher salaries in the regulatory affairs field.

RAPS RAC-US Exam Syllabus Topics:

Section	Objectives
Post-Approval and Lifecycle Management	- Marketed product compliance 1. Product changes and supplements 2. Adverse event reporting 3. Inspections and audits 4. Postmarket surveillance
Strategic Planning	- Regulatory strategy development 1. Regulatory pathway selection 2. Risk-benefit assessment 3. Product development strategy
Interfacing with Regulatory Agencies	- Regulatory communication and negotiation 1. Compliance management 2. Responses to agency inquiries 3. Meetings with regulators
Premarketing	- Product development and approval 1. Submission preparation 2. Labeling requirements 3. Clinical and nonclinical requirements 4. FDA interactions

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