Regulatory Writing Consultant | 50-80% FTE 6 month contract
A small biotech is seeking an experienced, independent Regulatory Writer with strong Regulatory oversight to drive their near-term IND submission and health authority interactions across the US/EU/UK. You’ll partner with their Regulatory Consultant and CRO to plan, author, and QC key dossiers and amendments supporting ongoing Phase II studies, with an eye toward accelerated pathways and Phase III/registration readiness.
Role:
- Author IND and submit by EOY, with EU and UK documentation being completed in Q1 2026
- Own authoring/QC of eCTD documentation: protocol & IB amendments, CTAs, PIPs, iPSPs, CSR’s, MAA components, and briefing packages
- Provide regulatory strategy input (US/EU/UK) that shapes development plans (fast track / BTD), leveraging FDA agency experience
Experience required:
- Oncology development experience (immuno-oncology/immunology strongly preferred)
- Strong FDA experience, IND authoring/submission and familiarity with expedited regulatory pathways
- Proven regulatory submission experience across US/EU/UK for PHIII / registration (MAA/BLA)
- Hands-on authorship of IND’s, PIP’s, iPSP’s, CTA’s, MAA’s, CSR’s, IB & protocol amendments
- Strong writing and regulatory affairs experience, able to review/author sections with minimal oversight keeping within tight timelines
- Experience with eCTD structure and publisher-friendly drafting.