Regulatory Writer

Novartis AG; United States; Hybrid; USD 65,000 - 121,000; Full time

Benefits offered by this job

Company vehicle

Car allowance

Job summary

Novartis is seeking a Regulatory Writer in London to transform complex science into clear regulatory documents. You will own multiple documents, collaborate with cross-functional teams, and guide clinical and submission activities while leveraging AI tools to enhance quality.

This role supports a hybrid work arrangement with global interfaces and ongoing development of regulatory submissions, ensuring compliance and high-quality documentation across regions.

Qualifications

• Requires degree in science, healthcare, regulatory affairs, or equivalent pharma experience.
• Medical writing or relevant pharma experience with regulatory knowledge.
• Strong understanding of medical writing processes and global regulatory environment.
• Biostatistics principles applied to regulatory documentation.
• Proven ability to collaborate and lead across cross-functional teams.

Responsibilities

• Author high-quality regulatory documents and manage multiple deliverables.
• Partner with cross-functional teams to develop clear regulatory content.
• Advise clinical and submission teams on writing standards and best practices.
• Contribute to data analysis planning and presentation of scientific information.
• Lead regulatory writing plans and timelines coordinating contributors.
• Participate in clinical trial and submission teams providing writing expertise.
• Apply AI tools to improve writing quality and efficiency.

Skills

Regulatory writing

Cross-functional collaboration

AI tools in writing

Scientific writing

Education

Science/regulatory degree

Job description

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.

Job Description

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.

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