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.
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