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Jump-start your regulatory career with a RAPS Regulatory Affairs Certificate

Offered in two tracks—pharmaceuticals and medical devices—with the option to take both together, RAPS Online University certificates offer well-recognized, flexible, and cost-effective regulatory education.

The Regulatory Affairs Certificate Program is an online series of courses you personalize to meet your professional development needs. Designed for regulatory professionals in their first five years in the regulatory field, this certificate program is comprehensive and flexible to help you achieve your goals.

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Each Regulatory Affairs Certificate Program is built on  a core curriculum of essential courses, including ethics, the role of the regulatory professional, global regulatory strategy and lifecycles & definitions.

You’ll customize the majority of your certificate program by hand-selecting individual electives from over forty courses across the topical areas of:

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Regulatory
Essentials
Medical
Devices
Pharmaceuticals
Quality
Clinical

These courses are designed to challenge your knowledge and provide the information you need to do your job better.

Regulatory Affairs Certificate Programs

Medical Devices

The following 4 courses are required as part of the program requirements in addition to 5 elective courses:

  • Ethics
  • Global Regulatory Strategy for Medical Devices
  • Medical Devices: Definition & Lifecycle
  • Role of the Regulatory Professional

Single Certificate
Member: $2,745 USD
Nonmember: $3,490 USD

Medical Devices & Pharmaceuticals (Dual)

The following 6 courses are required as part of the program requirements in addition to 8 elective courses:

  • Ethics
  • Global Regulatory Strategy for Medical Devices
  • Global Regulatory Strategy for Pharmaceuticals
  • Medical Devices: Definition & Lifecycle
  • Pharmaceuticals: Definition & Lifecycle
  • Role of the Regulatory Professional

Dual Certificate
Member: $4,080 USD
Nonmember: $5,150 USD

Pharmaceuticals

The following 4 courses are required as part of the program requirements in addition to 5 elective courses:

  • Ethics
  • Global Regulatory Strategy for Pharmaceuticals
  • Pharmaceuticals: Definition & Lifecycle
  • Role of the Regulatory Professional

Single Certificate
Member: $2,745 USD
Nonmember: $3,490 USD


Not sure if you’re ready to take on the dual certificate? You can always start with an individual certificate and upgrade to the dual when you’re ready for more!

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Elevate your certificate program by completing the Foundation in Regulatory Affairs (FRA) exam, which is included. Earning your FRA demonstrates to your peers and employers that you understand the fundamentals of regulatory affairs. It can better position you in the regulatory affairs job you have or the job you want. Once you pass the exam, you will earn a credential that allows you to display a digital badge and add it to your resume. Learn more >>

See why learners love our Online University
Certificate Program

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“I liked that I was able to select courses that were closely aligned with my job while also exploring other topics!”
Clare R.

“This certificate helped me build a foundation of knowledge for pursuing my career change. With this solid foundation, I’m more confident to pursue my career path.”
Raawa H.

I loved the Certificate Program because I was able to make it work for me, rather than the other way around. The self guided, self-paced courses allowed me to take the courses in my own time and be in control of my own schedule. I also really enjoyed that I was able to pick 5 out of the 9 courses and tailor my experience to what I wanted to focus on.
Kyla R.

Did you know? All online courses are also available individually!

Frequently Asked Questions

Will access be given to all courses at the time of registration?

Yes. You can access our learning products as soon as your purchase is confirmed. The courses will remain active under your account until 11:59 pm on the course closing date.

Do I need to take courses in a specific order? Are there prerequisites?

No. There is no specific order to taking courses and no prerequisites are required. The courses you take will depend on your experience in regulatory affairs, as well as your personal goals. In fact, most of our courses are designed to cover a certain topic and can be treated as its own entity. It’s believed that a good foundation of the regulatory framework will be helpful and certain courses are a good start and help you lay a good foundation for future professional development. Please click here to view a list of courses that are considered “essentials” for regulatory professionals. Besides all “essentials”, you can also find recommended course packages based on a different focus of regulatory affairs, such as medical devices, pharmaceuticals, quality or clinical. In addition to taking individual courses, you can also earn a certificate by taking our pre-packaged bundles for medical devices, pharmaceuticals, or a dual program for medical devices and pharmaceuticals.

When do I choose all my elective courses?

We recommend that you select all your elective courses at the beginning of your study, but you can choose to complete the core courses first. You will have to select all of your electives before you begin. If you need to change your electives as you advance, we can accommodate your request to change electives.

Can I exchange Certificate Program Courses?

Yes, but must meet the following criteria: Individuals with an active enrollment in a Regulatory Affairs Certificate may request to exchange an elective, provided the course has not been opened and has a “Not Started” status. Please note: After a course has been accessed it cannot be exchanged. *The close date for the Regulatory Affairs Certificate will apply to the replacement course.

Need a boost in
your career?

Enroll in a RAPS Online University
Certificate program