Expert Regulatory Writer

Location: London (The Westworks)

Salary Range

£67,900.00 - £126,100.00

Job Description Summary

#LI-Hybrid

Primary Location: London, United Kingdom (for candidates residing within 50 miles of the office)

Other Locations: Remote, United Kingdom (UK based candidates living more than 50 miles from the office)

Relocation Support: This role is based in London, United Kingdom. Novartis is unable to offer relocation support: please only apply if accessible.

Your expertise in regulatory writing can help transform complex science into clear, impactful documentation that supports medicines reaching patients worldwide. As an Expert Regulatory Writer at Novartis, you’ll take ownership of high-complexity regulatory documents and programmes, working closely with cross-functional teams to shape high-quality submissions. You’ll bring your expertise to complex challenges, influence best practices and help evolve how regulatory writing is delivered through collaboration, innovation and emerging technologies.

Key Responsibilities

• Lead the authoring of high-complexity regulatory documents, ensuring quality, accuracy, consistency and compliance.
• Provide expert regulatory writing guidance to clinical trial and submission teams.
• Partner with cross-functional teams to develop clear, scientifically robust regulatory content.
• Shape data analysis planning and the effective presentation of scientific information in regulatory documents.
• Lead regulatory writing plans and timelines, coordinating contributors to achieve critical submission milestones.
• Act as Program Writer for complex programmes, overseeing writing strategy, coordination, planning and resourcing.
• Champion best practices, new technologies and artificial intelligence tools to enhance regulatory writing quality and efficiency.
• Additional Locations: Home Worker