Explore jobs
Find specific jobs
Explore careers
Explore professions
Best companies
Explore companies
Best regulatory affairs specialist certifications
The best certifications for a regulatory affairs specialist are Regulatory Affairs Certification - US (RAC), Certified Clinical Research Professional (CCRP), and Certified Quality Auditor (CQA).
Regulatory affairs specialist certifications demonstrate your competency as a regulatory affairs specialist to employers. However, not all regulatory affairs specialist certifications provide the same value.
Below is a list of the best regulatory affairs specialist certifications. Obtaining a regulatory affairs specialist certification will give you a leg up when you apply for jobs and increase your potential salary.
7 best certifications for regulatory affairs specialists
| Rank | Regulatory affairs specialist certification | Organization |
|---|---|---|
| 1 | Regulatory Affairs Certification - US (RAC) | RAPS |
| 2 | Certified Clinical Research Professional (CCRP) | SOCRA |
| 3 | Certified Quality Auditor (CQA) | ASQ |
| 4 | Certified Pharmacy Technician (CPhT) | PTCB |
| 5 | Certified Clinical Research Coordinator (CCRC) | ACRP |
| 6 | Incident Safety Officer - Fire Suppression Certification (ISO) | FDSOA |
| 7 | Certified Billing and Coding Specialist (CBCS) | NHA |
7 best regulatory affairs specialist 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. Certified Pharmacy Technician (CPhT)
PTCB's pharmacy technician certification program enables technicians to work more effectively with pharmacists to offer safe and effective patient care and service. Certification is achieved by meeting specific eligibility requirements and earning a passing score on the Pharmacy Technician Certification Exam (PTCE). The PTCB certification program is accredited by the National Commission for Certifying Agencies (NCCA).
- More than two years of education or training after high school required? No
- More than two years of work experience required? No
- Oral or written exam required? Yes
- Renewal required? Every 2 year(s)
5. Certified Clinical Research Coordinator (CCRC)
Certification is increasingly recognized by today's global clinical research industry. Study sites use certification for documentation to sponsors and CROs that the site is professionally managed.Certification assists the public, healthcare professionals and the industry itself by identifying standards for professional practice.The written CRC examination is a measure of a candidate's knowledge of information needed for the CRC to perform this role effectively and the competent application of that knowledge in the conduct of clinical trials.
- 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)
6. Incident Safety Officer - Fire Suppression Certification (ISO)
A fire department incident safety officer's mission is to promote safety standards and practices in the fire, rescue and emergency services community. Members of the Fire Department Safety Officers Association, applicants sponsored by the Authority Having Jurisdiction (AHJ) and individuals meeting the duties and requirements of a company officer or an Incident Scene Safety Officer may apply.
- 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 5 year(s)
7. Certified Billing and Coding Specialist (CBCS)
A Certified Billing and Coding Specialist (CBCS) primarily focuses on converting a medical procedure, diagnosis, or symptom into specific codes to submit a claim for reimbursement.
- 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)
What is the best certification for a regulatory affairs specialist?
The best regulatory affairs specialist 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 specialist 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 specialists?
The most in-demand regulatory affairs specialist certification is Regulatory Affairs Certification - US based on all active job postings. Having this regulatory affairs specialist certification will give you access to more regulatory affairs specialist jobs with higher salaries.
What certifications can impact a regulatory affairs specialist career and salary?
The Regulatory Affairs Certification - US certification will help you to secure a regulatory affairs manager position, which will increase your pay and career trajectory. A regulatory affairs manager's average salary is $93,373 whereas regulatory affairs specialists make an average salary of $70,060.
The most common combination of regulatory affairs specialist certifications include: Regulatory Affairs Certification - US (RAC), Certified Clinical Research Professional (CCRP), and Certified Quality Auditor (CQA).
Online courses for regulatory affairs specialists 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. FinTech Law and Policy
Being a successful FinTech firm requires more than just great technology; it also requires an understanding of the laws and regulations applicable to your business. This course will provide you with that understanding. You will learn about the critical legal, regulatory, and policy issues associated with cryptocurrencies, initial coin offerings, online lending, new payments and wealth management technologies, and financial account aggregators. In addition, you will learn how regulatory agencies...
6. Drug Development
The University of California San Diego, Skaggs School of Pharmacy and Pharmaceutical Sciences Drug Development course brings you lectures from both faculty and industry experts. With this course, recorded on campus at UCSD, we seek to share our access to top people in the field who bring an unprecedented range of expertise on drug development. In this course you will learn the different stages of clinical development as well as the regulatory including but not limited to, an Investigational New...
7. Practical Regulatory Affairs 2020 - US FDA Medical Devices
A practical course discussing the US FDA Medical Device regulations for real-world situations...
8. 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...
9. 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...
10. Financial Regulation in Emerging Markets and the Rise of Fintech Companies
This course explores the developments that have fueled the emergence of fintech companies around the world. Following the changing regulatory environment, especially since the 1997 Asian and 2008 global financial crisis, governments have enacted far-reaching new financial regulations for safeguarding financial stability. However, banks and financial institutions have found it increasingly difficult to be profitable in these new regulatory environments. Technology is taking leaps forward in...
11. 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...
12. Practical Regulatory Affairs 2020 - European Medical Devices
A practical course discussing the EU Medical Device Regulation (MDR) in real-world situations...
13. 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...
14. 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...
15. 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...
16. 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...
17. ISO 9001, ISO 14001 & ISO 45001 Internal Auditor
Integrated Management System ISO 9001, ISO 14001 & ISO 45001 Internal Auditor...
18. Introduction to Compliance Risk Management CRM
Compliance risk management CRM for Compliance, Risk Management, Internal Audit and IS Security Professionals...
19. ISO 9001:2015 Internal Auditor
ISO 9001:2015 Quality Management System Internal Auditor...
20. ISO 13485 - IQOQPQ - Process Validation for Medical Devices
Installation Qualification (IQ), Operational Qualification (OQ) & Performance Qualification (PQ) Medical Devices...