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Regulatory Affairs Certification US is simply called RAC-US Certification Exam. It is a rigorous, technical exam consisting of questions across two disciplines - Pharmaceutical and Medical Devices. The exam is administered through the RAPS website which also serves as a platform for the RAC certification program. Candidates need to pass both the RAC-Drugs exam and RAC-Devices exam in order to achieve RAC-US Certification. Clinical qualification is not required for this exam. RAC-US exam dumps will help you to get prepared for the exam, with ease.
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Career growth: The RAC certification helps you to build a successful career by making you eligible to apply for high-profile positions in the pharmaceutical industry, government agencies, and non-profit organizations.
Increased salary: A RAC-US certified professional has an increased chance to get higher pay in their career. Companies that are looking to hire a regulatory affairs professional can consider hiring a RAC-US certified professional. You will be able to get a great advantage when you apply for the job because you have the RAC-US Certification.
Recognition: The RAC program provides recognition to the individuals who have achieved the certification. The RAC-US Certification also provides job opportunities and recognition to the candidates. The rate of employer sponsorship for this certification is very high. Hence, it is beneficial for all aspiring professionals and candidates.
Skill & knowledge: You will be trained to handle complex regulatory affairs. Moreover, you will gain experience and expertise to get better opportunities in the regulatory affairs profession. Client expense is also saved due to the reduced turnaround time.
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Details of the RAPS RAC-US Certification Exam
| Section | Objectives |
|---|---|
| Topic 1: Postmarket Compliance | - Device vigilance and recalls - Pharmacovigilance and adverse event reporting |
| Topic 2: Premarket Requirements | - Marketing authorization pathways (NDA, ANDA, PMA, 510(k)) - Labeling and promotional compliance |
| Topic 3: Quality Systems and Regulatory Operations | - Inspections and regulatory audits - GxP systems (GMP, GCP, GLP) |
| Topic 4: Product Development Lifecycle | - Drug and device development stages - Clinical trial frameworks and submissions (IND/IDE) |
| Topic 5: Regulatory Foundations | - US regulatory structure and agencies (FDA overview) - Regulatory ethics and compliance principles |
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