Top 11 Regulatory Affairs Specialist Certifications

Certifications for a regulatory affairs specialist are important in the job market because they demonstrate to potential employers that the individual is knowledgeable and qualified in the field. Certifications help employers quickly identify applicants who possess the necessary qualifications and experience to be successful in the role, as well as provide assurance that the individual is up-to-date on industry standards and regulations. Additionally, certifications can signify a higher level of expertise than what would otherwise be expected from someone without such an accreditation, helping to differentiate a candidate from other job seekers.

This article reviews some of the top certifications for Regulatory Affairs Specialists and explains how they can contribute to a regulatory affairs specialist's career.

What are Regulatory Affairs Specialist Certifications?

Regulatory affairs specialist certification is a professional credential that demonstrates an individual’s knowledge and expertise in regulatory affairs. Regulatory affairs specialists are responsible for ensuring that medical products, drugs, and other regulated items meet the requirements of applicable laws and regulations. The certification helps to demonstrate an individual’s commitment to the field and their ability to meet the needs of their employers.

Having a certification can help individuals stand out from the competition when it comes to job opportunities. It also demonstrates that they have taken the time and effort to gain knowledge in the field, which will be highly valued by potential employers. Additionally, having a certification provides evidence of an individual’s skillset in regulatory affairs and provides assurance that they are equipped with the necessary knowledge to handle complex tasks within this profession.

Furthermore, having a regulatory affairs specialist certification can provide individuals with access to exclusive resources, such as conferences and workshops related to regulatory affairs. This can help them stay up-to-date on changes in regulations or new industry developments while providing further insight into the profession. Additionally, it may allow them access to networking opportunities with peers or knowledgeable professionals within their field which could lead to career advancement or additional learning opportunities.

Pro Tip: When considering a Regulatory Affairs Specialist certification, make sure to research the program requirements and accreditation status of the provider. Certification programs that are accredited by a recognized body such as the Regulatory Affairs Professional Society (RAPS) will give you assurance that your certification is valid and reliable.

Related: What does a Regulatory Affairs Specialist do?

Top 11 Regulatory Affairs Specialist Certifications

Here’s our list of the best certifications available to Regulatory Affairs Specialists today.

1. Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professionals Society (RAPS)

Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professionals Society (RAPS) is a professional certification program designed to recognize individuals who have demonstrated expertise in regulatory affairs. The RAC program is designed to provide an objective assessment of an individual’s knowledge and experience in the field of regulatory affairs.

The RAC program consists of three parts: an online application, a comprehensive exam, and a practical experience requirement. The online application requires applicants to provide information about their educational background, work experience, and other relevant qualifications. Once the application is approved, applicants must pass a comprehensive exam that covers topics such as regulations and compliance, strategic planning and product development, quality assurance and risk management, communication and collaboration, project management and leadership. After passing the exam, applicants must demonstrate two years of full-time regulatory affairs experience or four years of part-time regulatory affairs experience in order to receive their certification.

It typically takes between six months to one year to complete the entire process from start to finish. The cost for the RAC program depends on several factors including whether you are a member of RAPS or not. For members of RAPS, the cost for the entire program is $1125 USD; for non-members it is $1350 USD.

2. Certified in Regulatory Compliance Management (CRCM) from the American Bankers Association

The Certified in Regulatory Compliance Management (CRCM) from the American Bankers Association is a professional certification that demonstrates an individual’s knowledge and understanding of regulatory compliance issues. It is designed to help financial services professionals stay current on the latest regulations, standards, and best practices in order to effectively manage risk and protect their organizations.

The CRCM exam consists of multiple-choice questions covering topics such as consumer protection laws, anti-money laundering regulations, deposit compliance, fair lending laws, and more. The exam takes approximately four hours to complete.

To become certified, individuals must meet certain eligibility requirements including having at least two years of experience in a banking or related field and passing the CRCM exam with a score of 70% or higher. Individuals can also obtain certification by attending an approved training program or completing a college course in regulatory compliance management.

The cost for the CRCM exam is $250 for members of the American Bankers Association and $350 for non-members. There may be additional costs associated with attending approved training programs or taking college courses.

3. Certified Regulatory Affairs Manager (CRAM) from the International Society for Pharmaceutical Engineering (ISPE)

The Certified Regulatory Affairs Manager (CRAM) from the International Society for Pharmaceutical Engineering (ISPE) is a professional certification program designed to recognize individuals who have demonstrated a high level of knowledge and expertise in the field of regulatory affairs. The CRAM certification is intended to provide assurance that an individual has achieved a certain level of proficiency in the area of regulatory affairs, and it is a valuable tool for employers when evaluating potential candidates for positions in this field.

To become certified, applicants must meet certain eligibility requirements and pass the CRAM examination. The eligibility requirements include having at least two years of experience working in regulatory affairs and completing an approved educational program or equivalent training. Once these requirements are met, applicants can register to take the exam which consists of multiple-choice questions covering topics such as regulatory compliance, quality systems, product development, manufacturing processes, and international regulations.

The cost of taking the CRAM exam varies depending on whether you are an ISPE member or non-member. For ISPE members, the cost is $395 USD while non-members pay $495 USD. The exam fee also includes access to online study materials and practice tests. It typically takes about 4-6 weeks to receive your results after taking the exam.

Once you have passed the exam, you will be awarded with your CRAM certification which is valid for three years before needing to be renewed. To renew your certification, you must complete continuing education credits or retake the exam every three years.

4. Certified Quality Auditor (CQA) from the American Society for Quality (ASQ)

Certified Quality Auditor (CQA) is a professional certification offered by the American Society for Quality (ASQ). It is designed to recognize individuals who have demonstrated knowledge and skills in auditing, as well as an understanding of quality management principles. The CQA certification is intended to demonstrate that an individual has the knowledge and ability to perform audits of quality systems.

To become certified as a CQA, you must pass an exam administered by ASQ. The exam consists of multiple-choice questions related to auditing, quality management systems, and other related topics. It typically takes about three hours to complete.

In order to take the exam, you must first apply for certification with ASQ. You will need to provide proof of education and experience that meet the requirements for CQA certification. Once your application is approved, you can register for the exam and pay the associated fee. The fee for taking the CQA exam varies depending on your country or region; however, it typically ranges from $250-$400 USD.

Once you have passed the exam, you will be officially certified as a Certified Quality Auditor (CQA). This certification is valid for three years from the date of passing the exam; after this time period expires, you must renew your certification by taking another exam or completing continuing education units (CEUs).

5. Certified Professional in Healthcare Quality (CPHQ) from the National Association for Healthcare Quality (NAHQ)

The Certified Professional in Healthcare Quality (CPHQ) is a professional certification provided by the National Association for Healthcare Quality (NAHQ). It is designed to recognize individuals who demonstrate expertise in healthcare quality through their knowledge, skills, and abilities. The CPHQ certification is a nationally recognized credential that validates an individual’s commitment to the field of healthcare quality.

To earn the CPHQ certification, applicants must have at least two years of full-time experience in a healthcare quality role and pass an exam administered by NAHQ. The exam consists of 175 multiple-choice questions covering topics such as patient safety, risk management, data analysis, performance improvement, and regulatory compliance.

The cost to take the CPHQ exam is $395 for NAHQ members and $495 for non-members. The fee includes access to study materials and practice exams. It typically takes about six months to prepare for the exam and complete all requirements necessary for certification.

6. Certified Clinical Research Professional (CCRP) from the Society of Clinical Research Associates (SOCRA)

The Certified Clinical Research Professional (CCRP) is a professional certification offered by the Society of Clinical Research Associates (SOCRA). It is designed to recognize individuals who have demonstrated knowledge and experience in clinical research. The CCRP credential is highly sought after by employers, as it shows that an individual has a comprehensive understanding of the principles and practices of clinical research.

To become certified, applicants must meet certain prerequisites, including having at least two years of full-time experience in clinical research or related activities. They must also pass an exam administered by SOCRA. The exam consists of multiple-choice questions on topics such as Good Clinical Practice (GCP), regulatory affairs, ethics, data management, and study design.

The cost for taking the CCRP exam varies depending on whether you are a member of SOCRA or not. For non-members, the fee is $400 USD; for members, it is $200 USD. The exam takes approximately three hours to complete and can be taken at any one of SOCRA’s testing centers located around the world. Once you have passed the exam, you will receive your CCRP certificate within two weeks.

7. Certified Regulatory Medical Writer (CRMW) from the Academy of Medical Writers

The Certified Regulatory Medical Writer (CRMW) credential is a professional certification offered by the Academy of Medical Writers. It is designed to recognize medical writers who have demonstrated expertise in regulatory writing, including clinical trial documents and other regulatory submissions.

To obtain the CRMW credential, applicants must meet certain eligibility requirements and pass an exam. To be eligible for the exam, applicants must have at least two years of experience in medical writing or related fields, such as clinical research or health sciences. Applicants must also submit a portfolio of their work that demonstrates their knowledge and proficiency in regulatory writing.

The exam consists of multiple-choice questions and takes approximately three hours to complete. The cost of the exam is $400 USD, which includes an application fee and a one-year membership to the Academy of Medical Writers. Once applicants pass the exam, they will receive their CRMW credential from the Academy.

The CRMW credential is valid for three years before renewal is required. Renewal requires completion of continuing education credits (CECs) as well as payment of a renewal fee ($200 USD).

8. Certified Regulatory Affairs Associate (CRAA) from the Academy of Pharmaceutical Sciences

The Certified Regulatory Affairs Associate (CRAA) from the Academy of Pharmaceutical Sciences is a professional certification that recognizes individuals who have achieved a high level of proficiency in the regulatory affairs field. The CRAA certification is designed to demonstrate an individual's knowledge and understanding of current regulations and guidelines, as well as their ability to apply them to pharmaceutical development projects.

It typically takes around 6-12 months to complete the CRAA program, depending on how much time an individual has available for study. In order to get certified, applicants must first pass an exam administered by the Academy of Pharmaceutical Sciences. This exam covers topics such as Good Manufacturing Practices (GMPs), Good Clinical Practices (GCPs), and other relevant topics related to regulatory affairs.

The cost of the CRAA certification varies depending on which package you choose. The basic package includes access to all course materials and the exam fee, while more comprehensive packages include additional resources such as practice exams, study guides, and mentoring sessions with experienced professionals in the field.

Overall, obtaining a CRAA certification can be beneficial for anyone looking to advance their career in regulatory affairs or become more knowledgeable about current regulations and guidelines in this field.

9. Certified Biomedical Industry Professional (CBIP® )from The Biomedical Science Careers Program

The Certified Biomedical Industry Professional (CBIP®) is a professional certification offered by The Biomedical Science Careers Program. This credential is designed to recognize and validate the knowledge, skills, and abilities of professionals working in the biomedical industry. It is intended to provide employers with an objective measure of a candidate’s qualifications for positions in the field.

To obtain the CBIP® credential, applicants must pass an exam that covers topics such as biomedical research and development, regulatory affairs, clinical trials management, product manufacturing, marketing and sales, quality assurance/quality control, and project management. The exam consists of 150 multiple-choice questions and takes approximately 3 hours to complete.

Applicants must meet certain eligibility requirements in order to take the CBIP® exam. These include having at least two years of experience in the biomedical industry or completing a minimum of 12 college credits in relevant courses. Applicants must also submit an application form and pay a fee of $350 USD before they can register for the exam.

Once applicants have passed the CBIP® exam, they will receive a certificate from The Biomedical Science Careers Program that is valid for three years from the date of issuance. Renewal requires successful completion of continuing education activities or retaking the CBIP® exam every three years.

10. Certified Regulatory Compliance Officer(CRCO™ )from The Institute of Internal Auditors

The Certified Regulatory Compliance Officer (CRCO™) is a professional certification program from The Institute of Internal Auditors (IIA). It is designed to provide individuals with the knowledge and skills necessary to effectively manage regulatory compliance within their organization. The certification focuses on the development of core competencies in areas such as risk management, compliance management, audit and control, and legal and regulatory requirements.

To become certified as a CRCO™, individuals must complete an online course that covers topics such as:

• Understanding the Regulatory Environment
• Risk Management
• Compliance Management
• Audit & Control
• Legal & Regulatory Requirements
• Professional Ethics & Responsibilities.

The course takes approximately 20 hours to complete and can be completed at your own pace. Upon successful completion of the course, you will receive a certificate of completion. You will then need to take an exam administered by IIA in order to receive your official CRCO™ designation. The exam consists of 100 multiple-choice questions and takes approximately 3 hours to complete. The cost for the exam is $395 USD for members of IIA or $495 USD for non-members.

11. Certified Regulatory and Clinical Research Professional(CRCRP™ )from The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use

The Certified Regulatory and Clinical Research Professional (CRCRP™) is an internationally recognized certification program from the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). It is designed to recognize individuals who are knowledgeable in regulatory and clinical research processes, procedures, and guidelines. The CRCRP™ provides a comprehensive understanding of ICH principles and practices, as well as best practices in regulatory affairs, clinical research, and quality assurance.

It typically takes between six months to one year to complete the requirements for certification. The process involves completing a series of online courses that cover topics such as global regulations, clinical trial design, data management, risk management, and quality assurance. Once all the courses have been completed, applicants must pass a written examination to demonstrate their knowledge of the material.

To become certified by the ICH as a CRCRP™ professional, applicants must first submit an application form along with proof of completion of all required coursework. After submitting the application form and passing the written exam, applicants will be awarded their certification.

The cost of becoming certified as a CRCRP™ professional varies depending on which courses you take and how long it takes you to complete them. Generally speaking though, it can cost anywhere from $500-$1,500 USD to become certified through this program.

Do You Really Need a Regulatory Affairs Specialist Certificate?

The short answer is no, you do not need a Regulatory Affairs Specialist Certificate in order to become a successful regulatory affairs specialist. However, having one can certainly be beneficial. A Regulatory Affairs Specialist Certificate can provide specialized training and knowledge that may be necessary for certain positions or to demonstrate your proficiency in the field.

Regulatory affairs specialists are responsible for ensuring that companies comply with government regulations and industry standards. They advise management on any changes that need to be made to meet these requirements and develop plans to ensure compliance. Having a Regulatory Affairs Specialist Certificate can give you an edge over other applicants by demonstrating your knowledge of the field and showing potential employers that you are committed to staying up-to-date on the latest developments in regulatory affairs.

Having a certificate may also help you stand out from other job seekers who don’t have specialized training or education in the field. It can give you an advantage when it comes to getting hired for certain positions, as well as helping you move up within the company once you’re hired. Additionally, some employers may prefer candidates who have a certification because it shows they are dedicated to their profession and have invested in their own development as a regulatory affairs specialist.

Overall, while having a Regulatory Affairs Specialist Certificate is not essential, it can certainly be beneficial if you want to pursue a career in this field. It may help make your resume more competitive and show potential employers that you are knowledgeable about the subject matter and take your career seriously.

Related: Regulatory Affairs Specialist Resume Examples

FAQs About Regulatory Affairs Specialist Certifications

Q1: What is a Regulatory Affairs Specialist Certification?

A1: A Regulatory Affairs Specialist Certification is an industry-recognized credential designed to demonstrate the knowledge and skills necessary to work in regulatory affairs. It typically involves completing an approved course of study, passing a comprehensive exam, and meeting any other requirements set by the certifying body.

Q2: How long does it take to become certified as a Regulatory Affairs Specialist?

A2: The amount of time needed to become certified as a Regulatory Affairs Specialist varies depending on the certifying body and program. Generally, it takes between 6 months and 2 years to complete all requirements for certification.

Q3: What are the benefits of becoming a certified Regulatory Affairs Specialist?

A3: There are many benefits to becoming a certified Regulatory Affairs Specialist. These include increased credibility in the field, improved job opportunities, higher salaries, and better career advancement prospects.

Q4: What qualifications do I need in order to become certified as a Regulatory Affairs Specialist?

A4: Most certifying bodies require applicants to have at least a bachelor’s degree in life sciences or related field, along with relevant experience working in regulatory affairs. Additionally, some programs may require additional courses or exams beyond those required for initial certification.

Q5: How much does it cost to become certified as a Regulatory Affairs Specialist?

A5: The cost of certification depends on the certifying body and program chosen. Generally speaking, applicants can expect to pay anywhere from $500-$3000 for tuition and associated fees for certification programs.