Why AI Is the Next Frontier in Regulatory Affairs — and How to Embrace It
May 7, 2025
📚 Whether you’re just starting out in Regulatory Affairs or looking to sharpen your foundation, having the right resources makes all the difference.
Here are a few resources I’ve found especially valuable for deepening my knowledge and staying current:
✅ Regulatory Affairs Professionals Society (RAPS) Regulatory Focus – concise updates on policy, guidance, and international trends
✅ FDA Guidance Documents – foundational for understanding regulatory expectations
✅ ICH Guidelines – essential for harmonizing global submissions (E2E, Q8, M4, etc.)
✅ Online certificates – platforms like DIA, RAPS, and Harvard Online offer focused, flexible learning
✅ LinkedIn + Conferences – Following thought leaders, joining webinars, and attending professional events keeps things fresh
If you’re new to the field or simply expanding your regulatory lens, a few things have helped me the most:
▪️ Focus on mastering one topic at a time (labeling, PV, or submissions—don’t rush)
▪️ Build your own reference library and revisit it regularly
▪️ Stay curious—learning never stops in this field
▪️ Engage in conversations—LinkedIn, webinars, and professional orgs are great places to start
Would love to know: What resources or tips have helped you in your pharma career? Drop your suggestions below ⬇️