Flexible Learning that Fits Your Schedule
Develop the knowledge and skills you need to succeed in regulatory affairs at your own pace and on your own schedule.
Choose a certificate path that aligns with your interests and gain practical knowledge developed by regulatory experts. Each certificate combines core coursework with elective options, allowing you to customize your learning experience while developing skills that can be applied immediately in the workplace.
Your Entry Point into Regulatory Affairs
These certificates are designed for professionals who are:
- New to regulatory affairs (typically within your first 0–5 years)
- Transitioning into regulatory from another function
- Students looking to enter regulatory
- Looking for structured, foundational regulatory knowledge
Choose Your Certificate Path
Strengthen your understanding of regulatory principles, terminology, and real-world practices so you can contribute more confidently in your current or future role. Compare the required coursework for our four certificate options:
Medical Device Regulations
Complete 4 required courses plus 5 elective courses to earn this certificate.
Required courses include:
- Ethics
- Global Regulatory Strategy for Medical Devices
- Medical Devices: Definition & Lifecycle
- Role of the Regulatory Professional
Choose your electives from a catalog of 20 courses based on your role, interests or career goals.
☑ Includes one FRA exam
Pharmaceutical Regulations
Complete 4 required courses plus 5 elective courses to earn this certificate.
Required courses include:
- Ethics
- Global Regulatory Strategy for Pharmaceuticals
- Pharmaceuticals: Definition & Lifecycle
- Role of the Regulatory Professional
Choose your electives from a catalog of 25 courses based on your role, interests or career goals.
☑ Includes one FRA exam
Medical Device & Pharmaceutical Regulations
Complete 6 required courses plus 8 elective courses to earn this certificate.
Required courses include:
- Ethics
- Global Regulatory Strategy for Pharmaceuticals
- Global Regulatory Strategy for Medical Devices
- Medical Devices: Definition & Lifecycle
- Pharmaceuticals: Definition & Lifecycle
- Role of the Regulatory Professional
Choose your electives from a catalog of 45 courses based on your role, interests or career goals.
☑ Includes two FRA exams
Regulatory Writing
Complete 2 required courses plus 3 elective courses to earn this certificate.
Required courses include:
- Regulatory Documentation: An Introduction
- Regulatory Writing: Plain Language
Choose your electives from a catalog of 5 courses based on your role, interests or career goals.
Why Learners Value RAPS Certificates
This flexible program allowed me to tailor the experience to my specific learning goals and company expectations. I would highly recommend the program to other professionals transitioning to regulatory from diverse backgrounds.
Taking courses online is a great option for someone employed full time. The coursework can be completed at your own pace and in any order. All courses offered opportunities to test your knowledge and review content as needed.
The material was clear and practical, making complex topics easy to understand. I feel more confident in my regulatory knowledge and would recommend this program to anyone interested in regulatory.
Designed to fit your busy schedule
Build the Learning Path That Works for You
- If you need foundational regulatory knowledge in one sector, start with a certificate in medical devices or pharmaceuticals.
- If you want foundational knowledge in both sectors, take the Certificate in Medical Device and Pharmaceutical Regulations.
- If you want to strengthen your communication skills, choose the Certificate in Regulatory Writing. This certificate can be taken:
- Alongside one of the foundational certificates
- After completing an essentials certificate program to deepen your effectiveness in your role
- On its own as a focused skill-building program
Earn a Credential
The Medical Device Regulations, Pharmaceutical Regulations and Medical Device & Pharmaceutical Regulations certificates include the opportunity to earn the Foundation in Regulatory Affairs (FRA) credential.
As you complete the coursework, you will build foundational regulatory knowledge across key concepts and practices. The FRA exam validates your understanding of these learning objectives.
Together, they provide both learning and recognition that helps you demonstrate your understanding of regulatory fundamentals and your readiness for regulatory responsibilities.