Senior regulatory writer

Senior Regulatory Writer

Senior Regulatory Writer | Remote/Hybrid | Global Regulatory Consultancy

A growing regulatory and medical writing consultancy is looking to hire an experienced Senior Regulatory Writer to support a broad portfolio of biotech, pharma, and clinical-stage clients.

This is a strong opportunity for someone who enjoys working across varied development programmes, partnering directly with clients, and leading the preparation of high-quality regulatory documentation in a collaborative, scientifically focused environment.

The Role

You will take ownership of core regulatory writing projects across clinical development programmes, working closely with cross-functional teams and external stakeholders to deliver accurate, concise, and submission-ready documentation.

Responsibilities include:

• Leading the preparation and review of key regulatory documents
• Interpreting and evaluating clinical development data
• Acting as a key client contact across multiple projects
• Supporting junior writers through mentoring and project guidance
• Managing timelines, budgets, and project deliverables
• Participating in client meetings and broader business development activities

Ideal Background

• Previous experience in regulatory writing within biotech, pharma, CRO, or consultancy environments
• Strong understanding of regulatory submission requirements
• Experience authoring core clinical and regulatory documentation
• Confident communicator with strong client-facing skills
• Able to manage multiple projects in a fast-paced setting
• Scientific degree or advanced life sciences qualification preferred

Why This Opportunity?

• Broad exposure across innovative biotech and pharma programmes
• High level of client interaction and project ownership
• Flexible working environment
• Collaborative and supportive culture
• Opportunity to contribute beyond delivery into strategy and business growth

If this could be relevant, feel free to get in touch for a confidential discussion.