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Novartis

Regulatory Writer

Novartis

. Author high-quality regulatory documents, managing multiple deliverables while maintaining accuracy, consistency and compliance .

Posted 11/10/2026full-timeLondon • United KingdomMid-LevelSenior💰 £49,140 - £91,260 per yearWebsite

Core Competencies

Role fit
Core Competencies

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Demonstrates expertise in regulatory writing and compliance, with a strong foundation in scientific knowledge and biostatistics principles. Proven ability to collaborate across teams and leverage artificial intelligence tools to enhance writing quality and efficiency.

Highest-signal resume keywords
Regulatory Writing ExpertiseBiostatistics PrinciplesCross-Functional CollaborationMedical Writing ProcessesArtificial Intelligence Tools

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills
Regulatory Document AuthoringData Analysis PlanningScientific Information PresentationRegulatory Writing StandardsCompliance Management
Soft Skills
Strong Communication SkillsOrganizational SkillsProactive Problem-SolvingAgility in Adopting New Technologies
Tools & Technologies
Artificial Intelligence Tools
Industry Keywords
Pharmaceutical Industry ExperienceGlobal Regulatory EnvironmentClinical Trial ParticipationSubmission MilestonesRegulatory Affairs

About the role

Key responsibilities & impact
  • 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

Requirements

What you’ll need
  • Degree in science, healthcare, regulatory affairs, or equivalent relevant pharmaceutical industry experience
  • Medical writing or relevant pharmaceutical industry experience
  • 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
  • Strong communication and organisational skills
  • Proactive problem-solving skills
  • Agility in adopting new technologies and leveraging artificial intelligence tools

Benefits

Comp & perks
  • Performance-based bonus eligibility
  • Insurance plans
  • Retirement plans
  • Wellbeing resources
  • Global recognition programs
  • Flexible and hybrid working options, where possible
  • Minimum 14 weeks paid parental leave
  • Company vehicle or car allowance eligibility, in accordance with applicable local policies and guidelines