Top 11 Regulatory Affairs Associate Certifications

Certifications for a regulatory affairs associate are important in the job market because they demonstrate to potential employers that the individual has the knowledge and skills necessary to be successful in the field. Certification shows that an individual is competent in their area of expertise and can handle the challenges posed by regulatory issues. Additionally, certifications provide evidence of an individual’s commitment to their profession and dedication to staying up-to-date on changes in regulations and industry trends. Employers may also view certifications as a sign of credibility, as it demonstrates that a candidate has gone through a rigorous process to become certified in their field. Ultimately, certifications can give regulatory affairs associates an edge over other job applicants, making them more attractive to employers.

The purpose of this article is to review some of the top certifications for Regulatory Affairs Associates and explain how they can help to advance a Regulatory Affairs Associate's career.

What are Regulatory Affairs Associate Certifications?

Regulatory affairs associate certification is a professional credential that recognizes an individual’s skills and knowledge in the regulatory affairs profession. It is designed to demonstrate to employers, colleagues, and clients an individual’s commitment to the highest standards of regulatory practice. The certification demonstrates that an individual has acquired the necessary knowledge, skills, and abilities required to successfully manage the complex regulatory requirements of their job.

Having a regulatory affairs associate certification can help individuals advance their career in regulatory affairs. It shows prospective employers that they are serious about their profession and have taken steps to acquire the necessary knowledge and experience needed for success. It also provides a competitive edge when applying for positions as it demonstrates an understanding of the current regulations and compliance issues associated with the regulated industry. Furthermore, having this certification can give individuals access to valuable networking opportunities which may open doors to new job opportunities or consulting work.

Pro Tip: When considering a Regulatory Affairs Associate Certification, look for programs that provide comprehensive and up-to-date coverage of the latest regulations and standards in the field. Additionally, make sure to research the reputation of the program you are considering, as well as its credentials and accreditations.

Related: What does a Regulatory Affairs Associate do?

Top 11 Regulatory Affairs Associate Certifications

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

1. Regulatory Affairs Certification (RAC)

Regulatory Affairs Certification (RAC) is a professional certification program designed to recognize individuals who demonstrate a high level of competency in the field of regulatory affairs. It is offered by the Regulatory Affairs Professionals Society (RAPS), an international non-profit organization dedicated to advancing the regulatory profession. The RAC certification provides recognition of expertise and experience in regulatory affairs, which can be beneficial for those seeking employment or advancement in the field.

The RAC certification requires applicants to pass an exam that covers topics such as regulatory strategy, compliance, quality systems, and global regulations. The exam consists of 150 multiple choice questions and takes approximately three hours to complete. To qualify for the exam, applicants must have at least two years of full-time experience in a regulatory role or equivalent education/training.

To get certified, applicants must submit an application along with their resume and supporting documentation. Once approved, they will receive instructions on how to register for the exam and pay the fee ($1,400 USD). After passing the exam, applicants will receive their certification within four weeks.

The cost of obtaining RAC certification includes a $100 application fee plus the $1,400 exam fee.

2. Certified Regulatory Affairs Professional (CRAP)

Certified Regulatory Affairs Professional (CRAP) is a professional certification program offered by the Regulatory Affairs Professionals Society (RAPS). It is designed to recognize individuals who demonstrate knowledge, skills, and abilities in regulatory affairs. The CRAP certification is generally considered to be the most prestigious certification in the regulatory affairs field.

To obtain the CRAP certification, applicants must pass an exam that covers topics such as regulations, compliance, and quality systems. The exam consists of multiple-choice questions and takes approximately three hours to complete. To be eligible for the exam, applicants must have at least two years of relevant experience in regulatory affairs or related fields.

In addition to passing the exam, applicants must also pay a fee of $450 USD for their application and $400 USD for their annual renewal fee. Once certified, CRAPs are required to maintain their certification by completing 30 continuing education credits every two years.

Overall, obtaining the CRAP certification can take several months from start to finish due to the time needed to study for and pass the exam as well as apply for and receive your certificate.

3. Certified Quality System Regulator (CQSR)

Certified Quality System Regulator (CQSR) is a certification program that evaluates and verifies the quality management systems of organizations. It is based on the ISO 9001:2015 standard and provides organizations with an external assessment of their Quality Management System (QMS). The CQSR certification process helps organizations to improve their QMS, identify opportunities for improvement, and demonstrate compliance with international standards.

The certification process typically takes around three to six months depending on the size of the organization and complexity of its processes. The first step in the process is to complete an initial application form which will be reviewed by an assessor. This initial review will determine if your organization meets the requirements for CQSR certification. If accepted, you will then need to submit a detailed QMS document outlining all aspects of your quality system including policies, procedures, processes, and records.

Once this document has been approved by an assessor, you will need to conduct an internal audit of your QMS to ensure it meets all requirements. This audit should include a review of all documents related to your quality system as well as interviews with key personnel in order to identify any areas for improvement. Once this audit is completed, you can request a formal assessment from a CQSR-accredited auditor who will review your QMS and issue a report detailing any non-conformances or areas for improvement.

Finally, once any corrective actions have been taken, you can apply for formal certification from CQSR which will involve another round of assessments and reviews before being issued with a certificate confirming your organization’s compliance with ISO 9001:2015 standards.

The cost of getting CQSR certified depends on several factors such as the size of the organization and complexity of its processes but typically ranges from $2,500 - $10,000 USD depending on these factors.

4. Certified Regulatory Compliance Manager (CRCM)

Certified Regulatory Compliance Manager (CRCM) is a professional certification that demonstrates an individual’s knowledge and expertise in the field of financial services compliance. The CRCM certification is offered by the Institute of Certified Bankers (ICB), which is part of the American Bankers Association (ABA).

The CRCM certification requires individuals to demonstrate a comprehensive understanding of banking regulations, compliance management systems, and risk management processes. To earn the certification, individuals must pass a comprehensive exam that covers topics such as consumer protection laws, anti-money laundering regulations, fair lending practices, and other related topics.

It typically takes about six months to prepare for the exam and complete all requirements for the CRCM certification. In order to be eligible to take the exam, applicants must have at least two years of full-time experience in regulatory compliance or related areas within the banking industry.

The cost of taking the CRCM exam varies depending on whether you are an ABA member or non-member. For ABA members, it costs $395 to take the exam while non-members pay $495. Additionally, there may be additional fees associated with registering for and taking the exam.

5. Certified Clinical Research Associate (CCRA)

A Certified Clinical Research Associate (CCRA) is a professional designation that recognizes individuals who have achieved a high level of knowledge and experience in the field of clinical research. CCRA certification is awarded by the Association of Clinical Research Professionals (ACRP), an international organization dedicated to advancing clinical research standards and practices.

To become certified, applicants must meet certain educational and professional requirements, including:

• Holding a bachelor’s degree or higher in a health-related field;
• Having at least two years of relevant experience in clinical research;
• Passing the ACRP Certification Examination.

The certification process typically takes three to six months to complete. The cost of becoming certified varies depending on the type of application submitted and whether or not an applicant has previously taken the ACRP Certification Examination. Generally, it costs between $500-$1,000 USD to become certified as a CCRA.

6. Certified Regulatory Medical Writer (CRMW)

A Certified Regulatory Medical Writer (CRMW) is a professional who specializes in the preparation of regulatory documents for medical products. These documents include clinical study reports, investigator brochures, and summary documents such as annual reports and periodic safety update reports. The CRMW certification is administered by the Regulatory Affairs Professionals Society (RAPS).

To become certified as a CRMW, an individual must have at least five years of experience in regulatory medical writing and pass an online exam. The exam consists of multiple-choice questions and covers topics such as clinical trial design, biostatistics, pharmacology, regulatory strategy, document preparation and review, and medical writing principles.

The cost to take the exam is $500 USD for RAPS members or $700 USD for non-members. It typically takes about two weeks to receive results from the exam. Once certified, individuals can use the CRMW designation on their resumes and other professional materials.

7. Pharmaceutical Industry Regulatory Affairs Certification Program (PIRACP)

The Pharmaceutical Industry Regulatory Affairs Certification Program (PIRACP) is an online program developed by the Regulatory Affairs Professionals Society (RAPS) to provide certification for professionals in the pharmaceutical industry. The program is designed to help individuals demonstrate their knowledge of regulatory affairs within the pharmaceutical industry and gain recognition for their expertise.

The PIRACP consists of two parts: a self-study course and a proctored exam. The self-study course includes seven modules that cover topics such as Good Manufacturing Practices, Quality Assurance, Regulatory Compliance, and Drug Development Processes. The proctored exam tests participants’ knowledge of the material covered in the course.

It typically takes about six months to complete the PIRACP program. To get started, individuals must register for the program and pay a fee of $1,295 USD. Once registered, they can access all of the materials needed to complete the program online. After completing the self-study course, participants must schedule a time to take the proctored exam at one of RAPS’ designated testing centers. Upon successful completion of both parts of the program, participants will receive their PIRACP certification.

8. International Society of Regulatory Professionals Certification Program (ISRP-CP)

The International Society of Regulatory Professionals (ISRP) Certification Program (ISRP-CP) is a professional certification program designed to recognize and validate the knowledge, skills, and abilities of regulatory professionals. It is an independent, third-party certification program that provides industry recognition for regulatory professionals who have met the rigorous standards established by ISRP.

The program consists of two levels: Certified Regulatory Professional (CRP) and Master Regulatory Professional (MRP). To become certified at either level, individuals must complete an application process that includes passing a comprehensive written exam. The exams are administered twice a year in May and October.

To become eligible to take the CRP exam, applicants must have a minimum of five years of experience in regulatory affairs or related fields, as well as three letters of recommendation from employers or colleagues in the field. For the MRP exam, applicants must have at least seven years of experience in regulatory affairs or related fields, as well as four letters of recommendation from employers or colleagues in the field.

The cost to apply for either level is $600 USD. Once accepted into the program, candidates will receive study materials and access to online resources to help them prepare for their exams. The exams themselves cost $400 USD each.

Once certified, individuals will receive an official certificate from ISRP acknowledging their achievement and may use their credentials on business cards and resumes. They will also be listed on ISRP’s website as certified professionals and gain access to exclusive networking opportunities with other members of the society.

9. American Association of Pharmaceutical Scientists Certification Program in Regulatory Science (AAPS-CPRS)

The American Association of Pharmaceutical Scientists (AAPS) Certification Program in Regulatory Science (CPRS) is a voluntary certification program that recognizes individuals who have demonstrated expertise in the field of regulatory science. The program was created to provide a standard for recognizing and validating the knowledge and skills of regulatory professionals.

To obtain the AAPS-CPRS certification, applicants must meet certain eligibility requirements, including having a minimum of three years of regulatory experience in the pharmaceutical industry or related field, and passing an examination. The exam consists of 150 multiple choice questions covering topics such as drug development, regulation and compliance standards, clinical trial design, pharmacovigilance, and manufacturing quality control.

The AAPS-CPRS certification is valid for five years from the date of successful completion of the exam. To maintain certification status, individuals must complete at least 30 hours of continuing education activities every two years.

The cost to take the AAPS-CPRS exam is $500 for members of AAPS and $800 for non-members. Additional fees may apply if an applicant needs to retake the exam or if they need to renew their certification after five years.

10. European Union Good Manufacturing Practice Certificate for Qualified Person of Medicinal Products and Active Substances

The European Union Good Manufacturing Practice (GMP) Certificate for Qualified Person of Medicinal Products and Active Substances is a certification issued by the European Medicines Agency (EMA) to individuals who are responsible for the release of medicinal products and active substances. The certificate is designed to ensure that those responsible for releasing these products have the necessary knowledge and experience in pharmaceutical production, quality control, quality assurance and regulatory affairs.

To obtain this certificate, an individual must demonstrate knowledge of GMP principles through a written test. The test can be taken at any EMA-approved examination centre and typically takes two hours to complete. The cost of taking the exam varies depending on the centre but generally ranges from €100-€200. After passing the exam, applicants must submit a detailed application form which includes information on their professional experience, qualifications and training in GMP principles. This application is then reviewed by an EMA expert panel before a decision is made on whether or not to issue the certificate.

Once approved, applicants receive their certificate within one month. It is valid for five years after which time it must be renewed by taking another written exam or submitting additional evidence of continuing education in GMP principles.

11. International Conference on Harmonisation – Good Clinical Practice Certificate

The International Conference on Harmonisation (ICH) Good Clinical Practice Certificate is an internationally recognized certification program designed to ensure that clinical research studies are conducted in accordance with the ICH GCP guidelines. The certificate is awarded by accredited organizations after successful completion of a training program and examination.

It typically takes two to three months to complete the training and obtain the certificate. The training consists of online modules, lectures, workshops, assessments, and other activities. The cost of the training varies depending on the organization providing it.

To obtain the ICH GCP Certificate, applicants must complete all required coursework and pass an examination administered by an accredited organization. Applicants must also demonstrate their knowledge of ICH GCP guidelines as well as their commitment to ethical research practices.

The cost of obtaining the ICH GCP Certificate varies depending on the organization offering it, but typically ranges from $500-$2000 USD.

Do You Really Need a Regulatory Affairs Associate Certificate?

The answer to this question depends on the type of career you are pursuing and your level of experience in the field. For someone just starting out, a Regulatory Affairs Associate Certificate (RAAC) can provide a good foundation in regulatory affairs and help you stand out from other applicants. It also shows employers that you are serious about the profession and have taken steps to gain the necessary knowledge.

On the other hand, if you already have some experience in the field, then a RAAC may not be necessary. Employers generally look for someone with several years of experience in regulatory affairs, as well as a deep understanding of the regulations and laws governing it. If you already possess these skills, then having a certificate may not be worth your time or money.

Ultimately, it is up to you to decide whether or not a RAAC is necessary for your goals. Consider your current level of knowledge and experience, as well as what career path you want to pursue before making your decision.

Related: Regulatory Affairs Associate Resume Examples

FAQs About Regulatory Affairs Associate Certifications

Q1. What is a Regulatory Affairs Associate Certification?

A1. A Regulatory Affairs Associate Certification is a credential that recognizes the knowledge, skills, and abilities necessary to work in regulatory affairs roles within the pharmaceutical industry. It is granted to individuals who have demonstrated the ability to understand and apply the regulations that govern drug development, manufacturing, marketing, and distribution.

Q2. What are the requirements for obtaining a Regulatory Affairs Associate Certification?

A2. The requirements for obtaining a Regulatory Affairs Associate Certification vary from one organization to another but generally include passing an exam and completing relevant coursework, such as a certificate program or other specialized training in regulatory affairs topics. Depending on the organization offering the certification, additional experience may also be required.

Q3. How long does it take to complete a Regulatory Affairs Associate Certification?

A3. The amount of time needed to complete a Regulatory Affairs Associate Certification varies depending on the organization offering it and any additional experience requirements they may have in place. Generally speaking, most certifications can be completed within one year with full-time study or two years with part-time study.

Q4. How much does it cost to obtain a Regulatory Affairs Associate Certification?

A4. The cost of obtaining a Regulatory Affairs Associate Certification typically includes fees for registration, exam preparation materials, and any additional coursework required by the organization offering it. These costs can range from several hundred dollars up to several thousand dollars depending on which certification you pursue and how much additional training you require to meet their qualifications for certification.

Q5 What are the benefits of having a Regulatory Affairs Associate Certification?

A5 Obtaining a Regulatory Affairs Associate Certification can provide numerous benefits including increased job security, higher salaries, access to more advanced positions within regulatory affairs departments of pharmaceutical companies, and greater recognition among peers in your field of expertise. Additionally, holding this certification demonstrates that you have met certain standards of knowledge and proficiency set by professional organizations in your area of expertise which can help you stand out when applying for jobs or promotions in regulatory affairs roles