Senior Regulatory Writer – Global Submissions

GB16 (FCRS = GB016) Novartis Pharmaceuticals UK Ltd.; Greater London; Hybrid; GBP 49,000 - 91,000; Full time

Benefits offered by this job

Flexible and hybrid working options

Parental leave (14 weeks minimum)

Performance-based bonus

Company vehicle or car allowance

Job summary

Novartis AG in London is seeking a Regulatory Writer to transform complex science into clear, regulatory-ready documents. You will work with cross-functional teams to develop high-quality submissions and ensure regulatory compliance across global documents.

The role involves ownership of multiple deliverables, collaboration with clinical and submission groups, and applying evolving technologies including AI tools to enhance writing quality and efficiency.

Qualifications

• Degree in science, healthcare, regulatory affairs, or equivalent relevant pharmaceutical industry experience.
• Medical writing or pharmaceutical industry experience, with strong regulatory knowledge.
• Strong understanding of medical writing processes and the global regulatory environment.
• Very good understanding of biostatistics principles and their application to regulatory documentation.
• Proven ability to collaborate and lead across cross-functional teams, with strong communication and organisational skills.
• Proactive problem-solving skills, with agility in adopting new technologies and leveraging artificial intelligence tools.

Responsibilities

• Author high-quality regulatory documents, managing multiple deliverables while maintaining accuracy, consistency and compliance.
• Partner with cross-functional teams to develop clear, scientifically robust regulatory content.
• Advise clinical and submission teams on regulatory writing standards, guidelines and best practices.
• Contribute to data analysis planning and effective presentation of scientific information in regulatory documents.
• Lead regulatory writing plans and timelines, coordinating contributors to achieve key submission milestones.
• Participate actively in clinical trial and submission teams, providing regulatory writing expertise throughout development.
• Apply evolving technologies, including artificial intelligence tools, to improve writing quality, efficiency and ways of working.

Skills

Regulatory writing

Cross-functional collaboration

Biostatistics knowledge

AI tools familiarity

Scientific writing

Education

Degree in science or related field

Job description

Novartis AG in London is seeking a Regulatory Writer to transform complex science into clear, regulatory-ready documents. You will work with cross-functional teams to develop high-quality submissions and ensure regulatory compliance across global documents.

The role involves ownership of multiple deliverables, collaboration with clinical and submission groups, and applying evolving technologies including AI tools to enhance writing quality and efficiency.