About the Role
Major Accountabilities
- Act as labelling lead for assigned products, developing and maintaining global core labelling documents and major market labels (e.g. CDS, USPI, EU SmPC/PIL).
- Organise and facilitate cross-functional labelling discussions (e.g. ELTF meetings) to support alignment on content.
- Collaborate with Global Labelling colleagues and cross-functional teams to ensure consistent, compliant, and competitive labelling content.
- Conduct research across competitor labels, regulatory guidance, and clinical data to inform labelling updates.
- Prepare documentation to support labelling changes and contribute to responses to Health Authority queries.
- Support timely implementation of labelling updates across countries, ensuring alignment with global standards.
- Maintain high-quality documentation, including version control, references, and rationale for changes.
- Support audit and inspection readiness, mentoring colleagues where appropriate, and contributing to continuous improvement initiatives.
Essential Requirements
- Fluency in English (written and spoken).
- Demonstrated capability in Global Labelling, Regulatory Affairs, or a related pharmaceutical discipline.
- Working knowledge of core labelling concepts and major market formats (e.g. CDS, USPI, EU SmPC/PIL).
- Ability to interpret clinical and safety data and translate it into clear, consistent labelling content.
- Strong attention to detail, with the ability to maintain accurate documentation and traceability.
- Ability to collaborate effectively across cross-functional teams and manage competing priorities.
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.
Role Requirements
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Benefits and Rewards: Learn about all the ways we’ll help you thrive personally and professionally.
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