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Best regulatory affairs manager certifications
The best certifications for a regulatory affairs manager are Regulatory Affairs Certification - US (RAC), Certified Clinical Research Professional (CCRP), and Certified Quality Auditor (CQA).
Regulatory affairs manager certifications demonstrate your competency as a regulatory affairs manager to employers. However, not all regulatory affairs manager certifications provide the same value.
Below is a list of the best regulatory affairs manager certifications. Obtaining a regulatory affairs manager certification will give you a leg up when you apply for jobs and increase your potential salary.
5 best certifications for regulatory affairs managers
| Rank | Regulatory affairs manager certification | Organization |
|---|---|---|
| 1 | Regulatory Affairs Certification - US (RAC) | RAPS |
| 2 | Certified Clinical Research Professional (CCRP) | SOCRA |
| 3 | Certified Quality Auditor (CQA) | ASQ |
| 4 | Clinical Trial Investigator (CTI) | ACRP |
| 5 | Certified Regulatory Compliance Manager (CRCM) | ICB |
5 best regulatory affairs manager certifications
1. Regulatory Affairs Certification - US (RAC)
The RAC (GS) exam is intended for regulatory professionals with 3-5 years of experience and is largely based upon knowledge and application of regulatory functions throughout the healthcare product lifecycle. It covers all product areas, including medical devices, IVDs, pharmaceuticals, medicinal products and biologics. Also covered on the exam are international standards and guidelines including those of ICH, GHTF, WHO and ISO.
- More than two years of education or training after high school required? Yes
- More than two years of work experience required? Yes
- Oral or written exam required? Yes
- Renewal required? Every 3 year(s)
2. Certified Clinical Research Professional (CCRP)
Clinical Research Professionals (CRPs) come from a wide variety of backgrounds. CRPs may have backgrounds in nursing, pharmacy, medical technology, business administration, health record maintenance, statistics, biology, teaching, or in other areas. CRPs work in various settings such as cooperative research groups; academic and private institutions; private offices; pharmaceutical, device, and biotechnology companies; Clinical Research Organizations (CROs); Site Management Organizations (SMOs); independent research and development organizations; or organizations involved in the management of clinical trials. These varying backgrounds and settings contribute to the unique knowledge and diverse expertise of CRPs.
- More than two years of education or training after high school required? Yes
- More than two years of work experience required? Yes
- Oral or written exam required? Yes
- Renewal required? Every 3 year(s)
3. Certified Quality Auditor (CQA)
The Certified Quality Auditor is a professional who understands the standards and principles of auditing and the auditing techniques of examining, questioning, evaluating and reporting to determine a quality system's adequacy and deficiencies. The Certified Quality Auditor analyzes all elements of a quality system and judges its degree of adherence to the criteria of industrial management and quality evaluation and control systems.
- More than two years of education or training after high school required? No
- More than two years of work experience required? Yes
- Oral or written exam required? Yes
- Renewal required? Every 3 year(s)
4. Clinical Trial Investigator (CTI)
Certification is granted in recognition of documented and verified work experience, education and after successful performance on a multiple-choice exam. The Academy offers the Clinical Trial Investigator Certification exam to qualified individuals. CTI certification signifies that a clinical research professional possesses a basic knowledge about the conduct of clinical trials and the responsibilities of clinical research. Certification assists the public, other healthcare professionals and the industry, by identifying standards for professional practice.
- More than two years of education or training after high school required? Yes
- More than two years of work experience required? Yes
- Oral or written exam required? Yes
- Renewal required? Every 2 year(s)
5. Certified Regulatory Compliance Manager (CRCM)
Applicable to financial services professionals whose primary function and expertise focus on the application, implementation and maintenance of relevant federal and state regulatory requirements as they relate to a financial services organization's business.
- More than two years of education or training after high school required? Yes
- More than two years of work experience required? Yes
- Oral or written exam required? Yes
- Renewal required? Every 3 year(s)
What is the best certification for a regulatory affairs manager?
The best regulatory affairs manager certification is Regulatory Affairs Certification - US (RAC). The Regulatory Affairs Certification - US (RAC) is awarded by the Regulatory Affairs Professionals Society. The advanced certification is for more experienced employees as it often requires some work experience to acquire.
Here's a bit more background on how to obtain this regulatory affairs manager certification:
- To become a certified Regulatory Affairs Certification - US (RAC), you need to pass the exam.
- This certificate requires more than two years of work experience.
- Renew certification every 3 year.
What are some of the most in-demand certifications for regulatory affairs managers?
The most in-demand regulatory affairs manager certification is Regulatory Affairs Certification - US based on all active job postings. Having this regulatory affairs manager certification will give you access to more regulatory affairs manager jobs with higher salaries.
The most common combination of regulatory affairs manager certifications include: Regulatory Affairs Certification - US (RAC), Certified Clinical Research Professional (CCRP), and Certified Quality Auditor (CQA).
Online courses for regulatory affairs managers to earn certifications
1. Regulatory Compliance
Every organization faces a myriad of risks that can threaten its operations, reputation, and bottom line. A robust, effective compliance program can make the difference between companies that successfully navigate those risks, and those that become cautionary tales.\n\nThis specialization will introduce the essential elements of effective organizational compliance by exploring the concepts, considerations, and strategies for assessing risks and managing the compliance function. You will learn...
2. Clinical Trials Operations
This specialization is designed for individuals and teams that will be running or interacting with clinical trials. In four courses, learners will develop insights and build the skills they need to design, manage, and monitor clinical trials as well as analyze, document, and communicate the results. Learners will also learn best practices regarding ethics, safety, participant recruitment, regulatory compliance, and reporting standards. The core principles and skills of the specialization will...
3. Pharmaceutical Industry Drug Regulatory Affairs (DRA)
Empowering Professionals in the Pharmaceutical Industry: A Comprehensive Online Course in Drug Regulatory Affairs...
4. Certificate Course in Drug Regulatory Affairs (DRA)
Pharma course (NDA, ANDA, CTD, DMF, USFDA, Regulatory strategy, GMP, Clinical Research, Orange Book, Pharmaceuticals)...
5. Cybersecurity Management and Compliance
In this course, you’ll learn about data and record management, Information security, standards and policy formation, and implementation. You’ll also explore cloud adoption frameworks and regulatory compliance frameworks. This course will take you one step closer to the Microsoft Cybersecurity Analyst Professional Certificate, which requires no degree or prior experience. After completing this course, you'll be able to: • Explain the principles of cloud security planning • Identify security...
6. Pharma Drug Regulatory Affairs Certificate Course - DRA 2023
DRA, Orange book, USFDA, e CTD, CTD, INDA, NDA, ANDA, DMF, ICH, Software Demo, RA Jobs, Quiz, Pharma Skills, Updated 2023...
7. Practical Regulatory Affairs 2020 - US FDA Medical Devices
A practical course discussing the US FDA Medical Device regulations for real-world situations...
8. EU Medical Device Regulatory Affairs explained Simply
How to get approval to sell Medical Devices within the European Union. Understand regulatory affairs & ISO 13485 2016...
9. Practical Regulatory Affairs 2020 - European Medical Devices
A practical course discussing the EU Medical Device Regulation (MDR) in real-world situations...
10. Medical Device Regulation 2017/745 EU regulatory affairs.
Understand regulations for medical devices in simple terms to gain market approval of a medical device in the EU...
11. Introduction to Compliance Risk Management CRM
Compliance risk management CRM for Compliance, Risk Management, Internal Audit and IS Security Professionals...
12. Medical Devices Quality Management System - ISO 13485:2016
Awareness and Application for the requirements of ISO 13485:2016 for Medical Device Development and QMS...
13. ISO 9001:2015-Quality Management System Implementation & Audit
Learn how to Implement and Audit a Quality Management System as per ISO 9001: 2015...
14. ISO 13485 Demystified - Medical Devices' QMS 360° Insights
Deep dive into the world of ISO 13485 international standard for medical devices' QMS, basic concepts & requirements...
15. The Simplest Guide to Clinical Trials Data Analysis with SAS
Step into the world of Pharmaceutical industry Clinical Trials Clinical Research Biostatistics Clinical SAS SAS...
16. ISO 9001:2015 Internal Auditor
ISO 9001:2015 Quality Management System Internal Auditor...
17. ISO 9001:2015 Quality management system auditor
Upgrade your career by learning how to implement and audit a quality management system according to ISO 9001...
18. ISO 9001, ISO 14001 & ISO 45001 Internal Auditor
Integrated Management System ISO 9001, ISO 14001 & ISO 45001 Internal Auditor...
19. Internal audit on Medical Device QMS - ISO 13485:2016
Successfully conduct an internal audit based on requirements of ISO 13485:2016 for Medical Device Development and QMS...
20. ISO 9001:2015 Quality Management Systems Lead Auditor Course
How to Implement & Audit an ISO 9001:2015 Quality Management Systems Lead Auditor/ Auditor course...