Regulatory Affairs Certification Worth It
The world's largest global organization that specializes in regulatory affairs in healthcare is the Regulatory Affairs Professional Society (RAPS). RAPS offers certifications for regulatory affairs in both devices and drugs known as RAC.
Cost of certification
How much does it cost to become a regulatory affairs specialist?
RAPS suggests that regulatory affairs specialists pursue a minimum of three years of work experience and join their network of over 25,000 members. Depending on whether an individual or a team is seeking membership, one or two-year tiers are available for $72 to $420.
Job opportunities with certification
What certifications do regulatory affairs specialists have?
Regulatory Affairs Specialists hold the Regulatory Affairs Certification - US (RAC), Certified Clinical Research Professional (CCRP), and Certified Quality Auditor (CQA) certifications.
Qualifications necessary for certification
What qualifications do you need to be a regulator?
To become a regulator, one must hold either a bachelor's degree with at least three years of regulatory experience, a master's degree with at least two years of regulatory experience, or a doctorate with at least one year of regulatory experience. The benefits of obtaining this certification program are numerous, but it is necessary to have the required qualifications to apply.
What subjects do you need to become a regulatory specialist?
To become a regulatory specialist, one must pursue relevant and necessary education, including a bachelor's degree in related fields such as biology, chemistry, pharmacology or technical science. It is recommended for high school students to focus on math and science classes.
Exams required to earn certification
What is a regulatory affairs certification (RAC)?
The Regulatory Affairs Certification (RAC) is a highly-valued professional credential that is a crucial investment for regulatory professionals in the healthcare product industry. It is considered the leading certification in this field. RAPS provides guidance on how to prepare for the RAC exam.
How many years of regulatory experience do you need?
To be eligible to take the RAC exams, one to three years of regulatory experience is required. The exams aim to test both knowledge and critical thinking skills needed in real-world situations. It is emphasized that the exam is not solely about content mastery. This information was sourced from an article on how to prepare for the RAC exam by RAPS.
How do regulatory professionals pass the exam?
Regulatory professionals need to allocate sufficient time to study the exam's content, evaluate their level of expertise, and create a preparation plan to successfully pass the Regulatory Affairs Certification (RAC) test. The exam's score ranges from 0 to 99, and a passing score is 75 or more.
Advantages of certification
How does regulatory affairs certification work?
Regulatory affairs certification enhances one's resume and reputation, irrespective of the industry or position applied for. To earn the certificate, one must pass a computer-based exam for one of four geographic areas: the United States, Canada, the European Union, or Global.
What are the benefits of a certification?
Certification offers numerous advantages, including the ability to recoup monetary costs through increased salary, the opportunity to expand one's professional network and industry expertise through study and renewal credit earning, and improved job prospects.
How do I view the Regulatory Affairs certificate tuition costs?
To view the tuition costs for the Regulatory Affairs Certificate, one can visit the Master's Program Costs website and scroll to the Regulatory Affairs section. Clicking on the title will expand and provide the tuition fee. Penn employees have access to tuition benefits, and more information about it can be obtained by visiting the Tuition Benefits page.
Accreditation of certifying body
What is an accreditation body?
Accreditation bodies - like UKAS and ANAB - are independent organizations that evaluate and accredit certification providers to ensure they adhere to international standards.
Why is accreditation so important?
Accreditation is highly significant because it enhances trustworthiness and significance of certification when the auditors and certification issuer abide by strict standards set by accrediting bodies such as UKAS/ANAB.
Continuing education requirements
What is a regulatory certification (RAC) and why do you need one?
A regulatory certification (RAC) is a demonstration of mastery and competency in regulatory affairs that sets you apart from certificate programs in continuing education. Having this certification gives you an advantage in getting recognized for advanced job positions in regulatory, making it valuable for standing out amidst competition.
What is a Dual Certificate in Regulatory Affairs?
The Dual Certificate in Regulatory Affairs is a program that allows individuals to explore multiple career paths within the regulatory affairs profession. The program provides foundational knowledge across different sectors, but it should be noted that it does not confer RAC status. To gain RAC status, individuals must pass one of the RAC exams.
How do I become a regulatory affairs professional?
Becoming a regulatory affairs professional does not depend on one specific degree or career path. Rather, successful individuals have diverse training ranging from science, pharmacy, engineering, marketing, and business. Such areas of cross-functional expertise typically equip professionals to be effective in regulatory affairs.
Maintenance of certification
What is the Regulatory Affairs certification (RAC)?
The Regulatory Affairs Certification (RAC) is a health care sector credential for professionals in regulatory career fields. It is offered by the Regulatory Affairs Professional Society and provides numerous benefits to those who obtain it.
What are the different types of Regulatory Affairs certifications?
RAPS provides two regulatory affairs certification options: RAC devices and RAC drugs. The RAC devices exam is intended for those with three or more years of experience dealing with medical devices and in vitro diagnostic products, while the RAC drugs exam caters to biotechnology and pharmaceutical regulatory professionals with three or more years of experience.
Why do job seekers need regulatory-related certifications?
Regulatory-related certifications can differentiate the experience of job seekers from similar candidates, thus making them more appealing to potential employers.
How much does a regulatory affairs manager make?
The average salary for a Regulatory Affairs Manager is $93,373. Additionally, obtaining the Regulatory Affairs Certification - US certification could potentially lead to career advancement in this field.
Professional organizations to join
What is the Regulatory Affairs Professional Society (raps)?
The world's largest global organization that specializes in regulatory affairs in healthcare is the Regulatory Affairs Professional Society (RAPS). RAPS offers certifications for regulatory affairs in both devices and drugs known as RAC.
What does a regulatory affairs professional do?
A regulatory affairs professional ensures compliance with global legislative and regulatory requirements throughout every stage of product development, specifically in the drug, medical device, and biologic product industries, which includes research and development as well as clinical trials.
