Interview readiness
Pass the interview
Every question a regulatory writing interviewer will ask — mapped to the exact week and deliverable that builds your answer.
Competency questions
The eight questions you'll be asked.
Walk me through the structure of a CTD and why it is organised that way.
What is the role of ICH E3 and how does it shape a Clinical Study Report?
How does a regulatory writer work with biostatistics when producing a CSR?
Tell me about a time you had to reconcile conflicting data in a document.
How do FDA and EMA approaches to safety summaries differ?
What is an Investigator's Brochure and when does it need updating?
Describe the lifecycle of an NDA or MAA submission.
How do you manage quality in a document under time pressure?
Curriculum mapping
Every answer is built somewhere in the programme.
| Question topic | Where you build the answer | Type |
|---|---|---|
| CTD structure | Week 4 builds document fluency across all five modules; Deliverable 3 (weeks 21–23) is a CTD module section. | Portfolio |
| ICH E3 and CSR | Week 7 covers E3 in depth; Deliverable 1 (weeks 13–17) is a full CSR section drafted and reviewed. | Portfolio |
| Working with biostatistics | Week 10 covers SAP reading; Week 11 covers cross-functional dynamics; CSR deliverable requires integrating statistical outputs. | Core weeks |
| Conflicting data | Week 11 stakeholder map exercise includes a scenario on conflicting reviewer comments. | Core weeks |
| FDA vs EMA on safety | Week 2 comparison table covers agency divergences; Week 5 covers RMPs. | Core weeks |
| Investigator's Brochure | Week 5 covers IB structure and update triggers; Deliverable 4 offers the IB update section. | Portfolio |
| NDA/MAA lifecycle | Weeks 1 and 5 together cover the full arc from IND to post-approval. | Core weeks |
| Quality under deadline | Week 8 covers document lifecycle and GDP; Week 12 document management plan. | Core weeks |
Commercial awareness
The questions that catch candidates out.
What recent regulatory approvals are you following and why?
How has MHRA's remit changed since Brexit?
What is an accelerated assessment pathway and when is it used?
How is AI changing regulatory submissions?
How to build commercial awareness
- Read RAPS Regulatory Focus weekly.
- Set Google Alerts for 'EMA approval', 'FDA approval' and 'MHRA guidance'.
- Follow MHRA on GOV.UK.
- Read EMA news and press releases.
- Pick two recent approvals and understand the submission story.
The framework
Structure your answer with STAR + G.
Situation
What was the document? What was the context (phase, therapeutic area, agency)?
Task
What specifically did you write? Which section? What was the brief?
Action
How did you approach it? What guidelines did you apply? What decisions did you make?
Result
What was the output? What feedback did you receive? What did you change?
Guideline
Which regulatory standard governed this? How did you ensure compliance?
Example answer · Deliverable 01
"Walk me through a regulatory document you've written."
I drafted Section 11.4 of a CSR — the overall efficacy results — from a completed Phase II oncology trial. The brief was to produce an ICH E3-compliant narrative integrating the primary and secondary endpoint TLF outputs. I applied the E3 structure, wrote in past tense using the published statistical outputs, and was careful to present the pre-specified primary analysis first before secondary data. In the senior writer review, the main feedback was that I had over-interpreted a secondary endpoint — so I revised to present it with appropriate epistemic hedging. The final section passed QC against our E3 checklist.