Top 11 Regulatory Specialist Certifications
This article provides an overview of the most popular and sought-after regulatory specialist certifications available today.
Published 18 min read
Certifications are an important part of a regulatory specialist’s job market success. Certifications provide a way to demonstrate knowledge and expertise in the field, which is necessary for employers to have confidence that the regulatory specialist has the necessary skills and qualifications. A certification from a reputable institution can also give potential employers assurance that the regulatory specialist is up-to-date on the most current regulations and best practices. Lastly, certifications help to differentiate candidates from other applicants who may have similar experience or education levels, giving those with certifications an edge in the job market.
The purpose of this article is to provide an overview of the most beneficial certifications for Regulatory Specialists and how they can help enhance their career prospects.
What are Regulatory Specialist Certifications?
Regulatory specialist certification is a credential that demonstrates an individual's comprehensive knowledge and expertise in regulatory affairs and related topics. It is awarded to individuals who have successfully completed the examination administered by a certifying organization or educational institution. This certification can be beneficial to professionals in the pharmaceutical, biotechnology, medical device, and other related industries.
The certification provides assurance to employers that the certified individual has the necessary expertise to ensure compliance with all applicable laws, regulations, and standards. A regulatory specialist with certification will demonstrate their commitment to professional development and present a higher level of competency in their field than an individual without it.
Having this certification can also help individuals advance their career prospects within their industry by providing them with a recognized credential that verifies their qualifications. Furthermore, having this certification may help individuals gain access to higher paying positions due to the increased demand for qualified personnel with regulatory expertise. Additionally, possessing this credential can help individuals stay abreast of current trends in regulatory affairs so they can better serve their employers and clients.
Pro Tip: Invest in a regulatory specialist certification program to stay up to date on the latest regulations and trends. This will ensure that you are well-equipped to handle any regulatory challenges that may arise in your profession. Certification can also be used as evidence of your commitment to professional development, which can be beneficial for career advancement.
Top 11 Regulatory Specialist Certifications
Here’s our list of the best certifications available to Regulatory Specialists today.
1. Certified Regulatory Compliance Manager (CRCM)
Certified Regulatory Compliance Manager (CRCM) is a professional certification offered by the Institute of Certified Bankers (ICB). It is designed to recognize professionals who have demonstrated expertise in regulatory compliance management. The CRCM certification is awarded to individuals who have met the requirements of the ICB's Certification Program, which includes passing an examination and meeting certain educational and experience requirements.
The CRCM exam consists of 200 multiple-choice questions covering topics such as consumer protection laws, bank operations, banking regulations, risk management, and financial services compliance. The exam takes approximately four hours to complete and costs $345 for members of the ICB and $395 for non-members.
To become certified, applicants must meet certain educational and experience requirements. Applicants must have at least three years of full-time work experience in regulatory compliance management or related fields; a bachelor’s degree from an accredited college or university; or a combination of education and experience that totals eight years. Additionally, applicants must pass the CRCM exam with a score of 70% or higher.
Once certified, CRCMs must maintain their certification through continuing education credits every two years. Continuing education credits can be earned through attending conferences, seminars, webinars, or other approved activities related to regulatory compliance management.
2. Certified Regulatory Affairs Professional (RAC)
Certified Regulatory Affairs Professional (RAC) is a professional certification program offered by the Regulatory Affairs Professionals Society (RAPS). The RAC credential is designed to recognize individuals who have achieved a high level of expertise in regulatory affairs and demonstrate their knowledge and understanding of the regulations, laws, and standards that govern the development and commercialization of medical products.
The RAC certification requires applicants to pass a comprehensive exam that covers topics such as regulatory strategy, product development, clinical trials, labeling and advertising, post-marketing surveillance, international registration, compliance management systems, and more. The exam consists of multiple-choice questions with five possible answers.
It typically takes six months to prepare for the RAC exam. During this time, applicants should review study materials such as textbooks or online courses related to regulatory affairs. Additionally, applicants should take practice exams to become familiar with the format of the real exam.
To obtain the RAC credential, applicants must submit an application to RAPS along with a fee of $425 USD ($325 USD for members). Once approved by RAPS, applicants will be eligible to sit for the RAC exam. Upon successful completion of the exam, applicants will receive their certification from RAPS.
3. Certified Regulatory Affairs Specialist (CRAS)
A Certified Regulatory Affairs Specialist (CRAS) is a professional who has demonstrated expertise in the field of regulatory affairs and compliance. This certification is offered through the Regulatory Affairs Professional Society (RAPS).
The CRAS certification requires applicants to have a minimum of three years of experience in regulatory affairs, as well as passing an exam. The exam consists of 150 multiple-choice questions covering topics such as global regulatory requirements, product development, quality assurance and compliance. The exam takes approximately four hours to complete.
To obtain the CRAS certification, applicants must submit an application to RAPS along with supporting documentation and fees. The fee for the CRAS exam is $1,095 USD for RAPS members and $1,295 USD for non-members. Additionally, there is a $50 USD fee for re-examination if needed.
Once an applicant has passed the exam, they will receive their official CRAS certificate from RAPS within two weeks. This certificate will be valid for three years before needing to be renewed.
4. Certified Regulatory Professional (CRP)
Certified Regulatory Professional (CRP) is a certification program designed to recognize individuals who have demonstrated knowledge and experience in the regulatory affairs field. The CRP credential is offered by the Regulatory Affairs Professionals Society (RAPS), an international, non-profit organization dedicated to advancing the regulatory profession.
The CRP program consists of two parts: a written exam and a practical application. The written exam covers topics such as regulatory strategy, regulatory compliance, and product development. The practical application requires applicants to demonstrate their skills in areas such as risk management, data analysis, and communication.
It typically takes 6-12 months to complete the CRP program. During this time, applicants must complete prerequisites such as coursework or professional experience in the regulatory affairs field before taking the written exam. After passing the written exam, applicants must then submit a portfolio of their work for review by RAPS’s Certification Board before they can be awarded the CRP credential.
The cost of obtaining a CRP credential varies depending on whether you are a member or non-member of RAPS. For members, it costs $595 for the written exam and $395 for the practical application; for non-members, it costs $795 for the written exam and $595 for the practical application.
5. Certified Quality System Regulation Professional (CQSRP)
Certified Quality System Regulation Professional (CQSRP) is a certification program developed by the American Society for Quality (ASQ). It is designed to recognize individuals who have demonstrated a comprehensive knowledge of quality system regulations and their application in industry.
The CQSRP certification consists of two parts: an exam and a portfolio review. The exam tests your knowledge of quality system regulations, including ISO 9000, FDA Good Manufacturing Practices (GMPs), and other related standards. The portfolio review assesses your experience with implementing quality systems in practice.
It typically takes about three months to complete the CQSRP certification process. To get certified, you must first pass the exam with a score of at least 70%. Then you must submit a portfolio that demonstrates your experience in implementing quality systems. Once both requirements are met, you will be awarded the CQSRP certification.
The cost of getting certified as a CQSRP varies depending on where you take the exam and what type of membership you have with ASQ. Generally speaking, it costs between $400-$600 to become certified as a CQSRP.
6. Certified Clinical Trial Administrator (CCTA)
A Certified Clinical Trial Administrator (CCTA) is a professional certification program that recognizes individuals who have demonstrated expertise in clinical trial management. The CCTA certification is awarded by the Association of Clinical Research Professionals (ACRP).
The CCTA certification requires applicants to demonstrate their knowledge and experience in clinical trial management, including the design, implementation, and oversight of clinical trials. Applicants must also pass an exam administered by ACRP.
It typically takes around 6 months to complete the CCTA certification process. To get started, applicants must first register with ACRP and submit their application materials. Once accepted into the program, applicants must then complete a series of online courses and assessments to prepare for the exam. After passing the exam, applicants are awarded their CCTA certification.
The cost of obtaining a CCTA certification varies based on individual circumstances and can range from $500-$2,000 USD depending on whether or not you are already an ACRP member.
7. Certified Medical Device Auditor (CMDA)
A Certified Medical Device Auditor (CMDA) is a professional certification that recognizes an individual’s expertise in medical device auditing. CMDA certification is offered by the International Standards Organization (ISO) and is designed to ensure that medical device auditors have the knowledge and skills necessary to perform their duties effectively.
To become a CMDA, individuals must first complete a training program approved by the ISO. The training typically takes between three and four days to complete and covers topics such as quality management systems, risk management, regulatory requirements, auditing techniques, and more. After completing the training program, individuals must pass an examination administered by the ISO in order to receive their certification.
The cost of becoming a CMDA varies depending on the training provider. Generally speaking, it can cost anywhere from $1,000 to $2,500 for the training program and exam fees combined. Additionally, there may be additional costs associated with travel and lodging if you choose to attend an in-person course.
Once certified as a CMDA, individuals are required to maintain their certification through continuing education credits every three years in order to remain current on best practices in medical device auditing.
8. International Society of Regulatory Professionals Certification Program (ISRP-CP)
The International Society of Regulatory Professionals Certification Program (ISRP-CP) is a professional certification program designed to recognize individuals who have demonstrated excellence in the field of regulatory affairs. The certification program is offered by the International Society of Regulatory Professionals (ISRP), an international non-profit organization dedicated to advancing the profession and practice of regulatory affairs.
The ISRP-CP requires applicants to demonstrate their knowledge and experience in regulatory affairs through a series of tests, interviews, and other assessments. To become certified, applicants must pass three main components: a written exam, an oral examination, and a practical assessment. The written exam covers topics such as regulatory principles, regulations, compliance management, and product development. The oral examination assesses applicants’ communication skills and their ability to explain complex topics related to regulatory affairs. Finally, the practical assessment evaluates applicants’ ability to apply their knowledge in real-world scenarios.
The entire process typically takes between six months and one year to complete. Applicants must submit an application form along with supporting documents such as transcripts or proof of work experience before they can take the exams. After successfully passing all three components of the certification program, applicants will receive their ISRP-CP certificate.
The cost for obtaining the ISRP-CP certification varies depending on each individual's circumstances but typically ranges from $1,000-$2,000 USD. This includes fees for taking the exams as well as any additional costs associated with preparing for them such as study materials or tutoring services.
9. Pharmaceutical and Biotechnology Regulatory Affairs Certification Program (PRAC-CP)
The Pharmaceutical and Biotechnology Regulatory Affairs Certification Program (PRAC-CP) is a professional certification program administered by the Regulatory Affairs Professional Society (RAPS). The PRAC-CP program provides a comprehensive foundation of knowledge and skills that are essential for regulatory affairs professionals in the pharmaceutical and biotechnology industries.
The PRAC-CP program consists of two parts: an online self-study course and an exam. The self-study course covers topics such as regulatory compliance, product development, post-marketing surveillance, and international regulations. The exam tests the candidate’s knowledge of these topics. To be eligible to take the exam, candidates must have at least three years of experience in regulatory affairs or related fields.
The self-study course takes approximately four weeks to complete, depending on the individual’s study habits and schedule. After completing the course, candidates can register for the PRAC-CP exam with RAPS. The exam fee is $400 USD for members of RAPS and $500 USD for nonmembers.
Once a candidate has successfully passed the exam, they will receive their PRAC-CP certification from RAPS. This certification is valid for five years from the date of passing the exam.
10. Health Care Compliance Association’s Certification in Healthcare Compliance (CHC)
The Certification in Healthcare Compliance (CHC) is a credential offered by the Health Care Compliance Association (HCCA). It is designed to recognize professionals who have achieved a high level of knowledge and expertise in healthcare compliance. The CHC credential is awarded to individuals who demonstrate proficiency in the areas of healthcare compliance, ethics, and risk management.
To obtain the CHC credential, applicants must have at least two years of professional experience in healthcare compliance or a related field. In addition, they must pass an examination that covers topics such as legal and regulatory requirements, enforcement actions, risk management strategies, and ethical considerations. The exam consists of 150 multiple-choice questions and takes approximately four hours to complete.
The cost for the CHC certification program varies depending on whether you take the exam online or at a testing center. Online exams typically cost $595 for HCCA members and $695 for non-members. If you choose to take the exam at a testing center, it will cost $795 for HCCA members and $895 for non-members.
Once you have successfully passed the exam, you will receive your CHC certification within six weeks. You will then be able to demonstrate your commitment to healthcare compliance through this prestigious credential.
11. Food and Drug Law Institute’s Advanced Certificate in FDA Law and Regulation (ACFLR).
The Food and Drug Law Institute’s Advanced Certificate in FDA Law and Regulation (ACFLR) is a comprehensive program designed to provide legal professionals with an in-depth understanding of the laws and regulations that govern the food and drug industry. The program is offered as a series of three courses, each of which covers a different area of FDA law. The first course focuses on the basics of food and drug regulation, including topics such as labeling, advertising, and enforcement. The second course explores more complex issues such as clinical trials, medical device regulation, and biologics regulation. Finally, the third course examines the legal implications of new technologies such as nanotechnology and gene editing.
The ACFLR program can be completed in six months or less depending on how quickly you complete each course. To get started, you must register for all three courses at once. Once you have registered for the program, you will receive access to online materials that include lecture recordings, case studies, quizzes, practice exams, and other resources to help you understand FDA law.
The cost of the ACFLR program varies depending on whether you are registering for individual courses or taking all three at once. If you choose to take all three courses together, it will cost $2195 plus any applicable taxes or fees. If you choose to take individual courses separately, it will cost $745 per course plus any applicable taxes or fees.
Overall, the ACFLR program provides legal professionals with an in-depth understanding of FDA law that can be used to better serve their clients in regulatory matters related to food and drugs.
Do You Really Need a Regulatory Specialist Certificate?
The short answer is no, you do not need a Regulatory Specialist Certificate to practice in the regulatory field. However, if you are looking to enhance your career prospects and develop your skills in this area, then a certificate may be beneficial.
A Regulatory Specialist Certificate can provide an individual with the necessary knowledge and understanding of the regulations that govern the industry they work in. It can also demonstrate an individual’s commitment to their profession, as well as increase their credibility when applying for positions or promotions. Additionally, having a certificate may help employers identify individuals who have specialized expertise in this particular field.
Having said that, it is important to remember that a Regulatory Specialist Certificate does not guarantee success in the regulatory field. A successful regulatory specialist will need to possess certain technical knowledge and skills such as understanding legal terms, researching relevant laws and regulations, analyzing data, and providing advice on compliance issues. Furthermore, they must also be able to communicate effectively with clients and colleagues.
Therefore, while obtaining a Regulatory Specialist Certificate may give an individual a competitive advantage over other job candidates or existing professionals in the field, it is ultimately up to them to demonstrate their competence through hard work and dedication.
FAQs About Regulatory Specialist Certifications
Q1: What is a Regulatory Specialist Certification?
A1: A Regulatory Specialist Certification is a professional certification that demonstrates an individual's knowledge and expertise in the regulatory environment related to their field. This includes understanding of laws, regulations, policies, and procedures relevant to their industry.
Q2: Who should pursue a Regulatory Specialist Certification?
A2: Professionals who are involved in the development, implementation, or enforcement of regulations in their field should consider obtaining a Regulatory Specialist Certification. This includes those who work in government agencies, consulting firms, and private companies.
Q3: What are the benefits of having a Regulatory Specialist Certification?
A3: Having a Regulatory Specialist Certification can provide individuals with recognition of their expertise and knowledge in their field as well as increase their job opportunities. The certification also helps demonstrate compliance with government regulations and standards which is beneficial for employers.
Q4: What does it take to become certified as a Regulatory Specialist?
A4: To become certified as a Regulatory Specialist, individuals must pass an exam administered by the applicable regulatory body or organization. Depending on the specific requirements of the certifying body, additional training may be required prior to taking the exam.
Q5: How long does a Regulatory Specialist Certification last?
A5: Generally speaking, most certifications have an expiration date that must be renewed every two years or so depending on the particular certification program. It is important to stay up-to-date on any changes to regulations or policies that may affect your certification status.