1 | Why Regulatory Affairs Matters
Every new drug or device requires regulatory approval.
RAPS certifications prove you understand global compliance frameworks and can communicate with agencies.
2 | FRA (Beginner)
- No experience required.
- Online, 60 min exam.
- Topics: drug/device lifecycles, submission basics, compliance.
- Cost ≈ $200–$300.
Best for: Students or career changers into RA.
3 | RAC (Advanced)
- Experience: Bachelor + 3 yrs (or Master + 2).
- 120 questions · 2.5 hrs.
- Regions: US, EU, Global, CAN.
- Cost ≈ $590–$740.
- Renewal: 36 CE credits / 3 yrs.
4 | Key Differences
| Feature | FRA | RAC |
|---|---|---|
| Level | Entry | Professional |
| Mode | Online | Proctored |
| Experience | 0 yrs | 2–3 yrs |
| Recognition | Introductory | Global standard |
| Avg Salary Boost | +5–8 % | +15–25 % |
5 | Career Impact
RAC holders advance faster to Regulatory Manager or Director roles and command $110–140 k+ salaries.
6 | Study Resources
- RAPS Fundamentals of Regulatory Affairs textbook.
- RAC Candidate Handbook.
- Clinical Research Exam Prep Test Banks