Regulatory Affairs Certificate (RAC)

What is the importance of RAC?

In these times, there is so much importance given to proper understanding of the regulatory environment from employees in the pharmaceutical, biotech, and medical device manufacturing companies – or other related fields – in which they work. This certificate program has been developed for employees working in pharmaceutical, biotech, and medical device manufacturing companies and dealing with regulatory and FDA issues in the workplace, those in the legal profession working with FDA law and regulations, and others interested in the field. Participants will obtain a general understanding of the Regulatory Affairs environment, a comprehensive knowledge of the FDA and its related functions, an understanding of FDA requirements encompassing the manufacture of drugs and vaccines, the risks and costs of non-compliance, and an understanding of the operation, timetable and techniques used to get a product to market.

Why do you need to certify?

Regulatory Affairs is an excellent career for professionals who wish to work in a challenging and dynamic field where field of science, business, government and most importantly, saving people’s lives, are the nuclear of their daily operations. 

The fundamental purpose of any professional certification program is to offer an independent, dependable assessment of the knowledge and skills comprehension required for having an edge in performing a professional role. This assessment, like any other, is typically accomplished by the successful completion of the given examination.

The Regulatory Affairs Certificate provides professionals with a comprehensive and balanced education and training concentrating on the fundamental areas of Regulatory Affairs and the FDA imposed regulations relevant to the pharmaceutical and biologics industry. The certificate covers a wide array of necessary technical and business skills to meet specific work requirements. It is designed to provide an elemental preparation to professionals who want to participate in the process of drug development as regulatory and quality assurance and control professionals as well as provide a basic understanding to other experts involved directly in drug development process, such as chemists, pharmacologists, and biologists.

The Regulatory Affairs Certificate, which was developed from the increasing demands by the industry, offers a well-rounded career growth and opportunities for participants interested in the Regulatory Affairs industry. MITS’ RAC course program will enable participants to transition into the life science industry and launch careers as regulatory and compliance professionals. 

Certificate Benefits

• Gain insights on the practical applications for ensuring regulatory compliance as required by the FDA regulations for Biologics and Drug development
• Explore Good Documentation Practices for companies executing activities regulated by the FDA
• Learn and adapt on the current trends in drug safety and the importance of GLP regulations
• Cultivate the knowledge and skills needed to into the the Advanced Studies for Regulatory Science certificate

What are the requirements needed to be able to earn the certificate?

The Regulatory Affairs Professional Society (RAPS) requires all applicants to have either a bachelor’s degree or at least three years of experience as a regulatory professional. The RAC application is available to submit online through the RAPS website, though candidates may choose to send it by fax or mail but these may require some payment fee.

At the time of publication, the exam fee was $535 for nonmembers and $325 for members. The nonmember fee includes a year of membership in RAPS. There are two testing windows for the RAC: April 1st through May 30th and October 1st through November 30th. The application deadline is February 15th for the spring testing window and August 15th for the fall window. Late registration has an additional fee of $100.

What is the kind of exam given in RAC?

RAPS will send you an email with instructions to schedule your exam (which take place in computer-based testing centers around the country), within around 10 business days of RAPS receiving your application. The RAC exam contains 100 multiple-choice questions, and examinees are given two hours to completely finish the said exam.

The exam is divided into four domains: strategic planning, pre-approval, approval and post-approval. Each domain tests your knowledge of the necessary actions and responsibilities of regulatory affairs professionals during that step in the regulatory process. In each domain, there are a roughly equal number of recall, application, and analysis questions.

How can you prepare for the exam?

Like any other certification exams, you need to attend a training course to guide and prepare you in taking the RAC certification exam. MITS offers a training course for the same purpose. With our rigorous training, exercises, activities, and engaging lectures, we provide all necessary required knowledge and skills to make you earn that certificate.

How can you maintain your certification?

Recertification for the RAC occurs every three years. Certified professionals must have 36 recertification credits to maintain their RAC. These recertification credits can be earned by taking part in a number of activities beneficial to regulatory affairs professionals. These activities include participating in training or educational programs on topics relevant to regulatory affairs professionals, organizing courses or speaking at regulatory affairs events, obtaining additional industry certifications, publishing books or articles, and involving in the leadership of industry organizations.