Expert Regulatory Writer

GB16 (FCRS = GB016) Novartis Pharmaceuticals UK Ltd.; Greater London; Hybrid; GBP 68,000 - 126,000; Full time

Benefits offered by this job

Insurance plans

Retirement plans

Wellbeing resources

Global recognition programs

Flexible hybrid working

Job summary

Novartis AG in London is seeking an Expert Regulatory Writer to own high-complexity regulatory documents and programs, collaborating with clinical and submission teams to shape high-quality submissions.

You will lead writing plans, coordinate contributors, and leverage AI tools to raise standards in regulatory writing across global submissions.

Qualifications

• Degree in science, healthcare, regulatory affairs or equivalent experience.
• Strong medical writing or regulatory industry experience with scientific knowledge.
• Deep understanding of regulatory writing processes and global environment.
• Advanced biostatistics understanding applied to regulatory docs.
• Proven cross-functional collaboration and strong communication.

Responsibilities

• Lead authoring of high-complexity regulatory documents ensuring quality and compliance.
• Provide expert regulatory writing guidance to trial and submission teams.
• Collaborate with cross-functional teams to craft robust regulatory content.
• Shape data analysis planning and presentation of scientific information.
• Lead writing plans and timelines, coordinating contributors for milestones.
• Act as Program Writer for complex programmes, managing strategy and resourcing.
• Champion best practices and AI tools to enhance writing quality and efficiency.

Skills

Regulatory writing

Cross-functional leadership

Medical writing

Biostatistics

AI tools

Communication

Education

Science degree

Tools

AI tools

Job description

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.

Job Description 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.

Essential Requirements

• Degree in science, healthcare, regulatory affairs, or an equivalent combination of education and relevant pharmaceutical industry experience.
• Strong medical writing or relevant pharmaceutical industry experience, combined with scientific and regulatory knowledge.
• Expert knowledge of medical writing processes and the global regulatory environment.
• Advanced understanding of biostatistics principles and their application to regulatory documentation.
• Demonstrated cross-functional leadership, with strong collaboration, communication and organisational skills.
• Ability to solve complex problems proactively and adopt new technologies, including artificial intelligence tools.

Benefits & Rewards

Expected Annual Base Salary Range for role: £67,900 to £126,100 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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