Senior Regulatory Medical Writer

An international clinical research organisation is looking to appoint a Senior Regulatory Writer to join its growing regulatory writing team.

This role would suit an experienced regulatory writing professional who enjoys working across complex clinical development programmes and wants to play a visible role supporting sponsor-facing regulatory activities within a collaborative CRO environment.

The team is looking for someone who is confident managing regulatory documentation independently, comfortable coordinating across multiple stakeholders and able to contribute strategically across the wider submission process.

The opportunity

You’ll take ownership of a broad range of regulatory and clinical documents across oncology programmes, supporting studies throughout different stages of development and submission activity.

Alongside document preparation, you’ll work closely with sponsors, medical teams and operational colleagues to coordinate timelines, manage review cycles and ensure documentation is aligned with regulatory expectations and project objectives.

The role offers strong exposure across cross-functional teams and would suit someone who enjoys balancing scientific accuracy, organisation and stakeholder management within a fast-moving environment.

Experience they’re hoping to see

• 5+ years’ experience within a CRO, biotech or pharmaceutical environment
• Strong background in regulatory writing within oncology
• Experience leading the preparation of regulatory documentation including Clinical Study Protocols, Clinical Study Reports, Investigator Brochures, IND applications and DSURs
• Familiarity with Fast Track Applications and accelerated submission pathways
• Experience coordinating sponsor reviews, timelines and document workflows
• Understanding of eCTD structures and regulatory submission requirements
• Ability to manage multiple projects simultaneously and work independently
• Strong written communication and stakeholder management skills
• A highly organised and detail-focused approach

What makes this opportunity interesting

• Broad involvement across oncology-focused regulatory programmes
• Client-facing exposure with direct sponsor interaction
• Opportunity to contribute across the full regulatory documentation lifecycle
• Visible role within a growing regulatory writing group
• Fully remote working available across the UK

Apply now.

For more information, please contact Nicky Stunt, Principal Healthcare Communications Recruiter, at nicky.stunt@rbwconsulting.com