26-week programme · Regulatory Medical Writing
The Regulatory Writing OS
From zero to interview-ready. A structured 26-week curriculum covering the language, architecture and conventions of regulatory medical writing — with real documents, real resources, and a portfolio you can take into any interview.
The Curriculum
Two phases. Twenty-six weeks.
One portfolio.
Foundation
- FDA / EMA / MHRA / ICH remits
- IND, CTA, NDA, MAA, CTD, CSR, IB, RMP
- ICH E3, E6, E9, M4
- Reading protocols and SAPs
- Cross-functional team dynamics
Applied Portfolio
- CSR section from protocol and statistical outputs
- MHRA regulator query response
- CTD module section
- Advanced deliverable scoped to career direction
How it works
Built like a real regulatory writing job —
not a tidy classroom.
Real resources, not summaries
Every link is an official guideline, real CSR or published article. You learn from the same sources working writers use.
Practical tasks every week
Every week ends with a real drafting exercise. By week 12 you've already produced a portfolio's worth of practice.
Interview-mapped
Every interview question a regulatory writer faces is mapped to the exact week and deliverable that builds the answer.
Portfolio-first
Four real deliverables. Senior writer review cycles. A portfolio you can take into any regulatory writing interview.
Guidelines you'll know inside out
Ready to start?