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Regulatory writer - remote

Lyne
Meet Life Sciences
Regulatory writer
Posted: 28 June
Offer description

Job Description

We are currently partnering with a leading global medical communications agency to support their search for an experienced Regulatory Medical Writer. This is a fantastic opportunity to contribute to meaningful regulatory submissions across a variety of therapeutic areas, working with a highly collaborative and well-established team.


About the Role:

This position involves the development of high-quality, accurate, and compliant documentation to support global regulatory submissions. You will work closely with internal teams and external clients to ensure that deliverables meet both scientific and regulatory standards.


Key Responsibilities:

1. Write and edit a variety of regulatory documents (e.g., clinical study reports, protocols, CTD clinical summaries, investigator brochures) across multiple therapeutic areas
2. Ensure all documents are clear, accurate, and aligned with relevant regulatory guidelines and client expectations
3. Review and quality-check clinical documentation, data outputs, and other supporting materials
4. Liaise with client teams to manage timelines, address queries, and resolve content or compliance issues
5. Conduct background research to confirm references and stay aligned with current regulatory requirements
6. Work across multiple projects while maintaining high standards and meeting deadlines

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