Regulatory Writer

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

Job Description Summary

Salary Range: £49,140.00 - £91,260.00 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 writing can help turn complex science into clear regulatory documents that support medicines reaching patients. As a Regulatory Writer at Novartis, you’ll work closely with cross-functional teams to develop high-quality regulatory documentation, bringing together scientific insight, regulatory knowledge and strong writing skills. You’ll take ownership of multiple documents, contribute to clinical and submission teams, and use evolving technologies, including artificial intelligence tools, to enhance the quality and efficiency of regulatory writing.

Key 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.

Essential Requirements

• Degree in science, healthcare, regulatory affairs, or equivalent relevant pharmaceutical industry experience.
• Medical writing or relevant pharmaceutical industry experience, with strong scientific and 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.

Benefits & Rewards

At Novartis, we’re committed to reimagining medicine together - and rewarding the people who make it happen. Expected Annual Base Salary Range for role: £49,140 to £91,260. The base salary offered is determined based on gender-neutral objectives, such as relevant skills, competencies and experience in accordance with the Novartis pay setting policy and upon joining Novartis will be reviewed periodically. In addition to your base salary, you may be eligible for a performance-based bonus depending on certain performance parameters. The rewards of being part of our team go far beyond base pay and incentives. We also offer a variety of competitive benefits in kind to help you thrive personally and professionally, such as insurance plans, retirement plans, wellbeing resources and global recognition programs. In addition, we provide flexible and hybrid working options, where possible, and minimum 14 weeks paid parental leave. You may be eligible for a company vehicle or a car allowance in accordance with the applicable local Novartis policies and guidelines.

Pay equity is a fundamental principle of our employment policy and reflects our commitment to create a diverse, equitable and inclusive environment that treats all employees with dignity and respect, as outlined in our Code of Ethics. Read our brochure to learn more about our global total rewards offering: https://www.novartis.com/sites/novartis_com/files/novartis-life-handbook.pdf Note: Benefits and compensation may vary by country and are subject to local legal requirements, including provisions of collective bargaining agreements where applicable. A full overview of your compensation package, including any relevant collective bargaining agreement details applicable to your role based on your employment location and Novartis employer entity, will be communicated separately to you during the application process.

Commitment to Diversity and Inclusion / EEO paragraph

Novartis is committed to building an outstanding, inclusive work environment and diverse teams’ representative of the patients and communities we serve.

Skills Desired

Improving the lives of people living with disease takes more than innovative science. It takes a focus on the needs of people and a community committed to meeting them. It takes a team of people like you. Working together. Learning together. Thriving together. Discover how you can join us in changing people’s lives.

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