Summary
About the Role
Key Responsibilities:
- Serve as labelling lead for assigned products, developing and maintaining compliant global labelling documents (e.g., CDS, BPL, BSS, IFU) and major market labels (USPI/PPI/MG, EU SmPC/PIL and other priority countries).
• Organize and lead ELTF meetings to align content and comments, as appropriate for level.
• Collaborate with Global Labelling Directors / Associate Directors to ensure aligned, compliant, and competitive labelling content across assigned tasks. Flex on projects from Director or AD GL.
• Conduct detailed research across competitor labels, global regulations and study information to support content development.
• Prepare documentation supporting CDS changes and contribute to responses to Health Authority queries.
• Ensure timely country implementation of labelling changes and compliance with CDS requirements.
• Mentor newcomers and support readiness for audits, inspections and continuous improvement initiatives.
• Maintain appropriate document quality and traceability (version control, references and rationale) to support governance requirements and audit readiness.
• Development and maintenance of IPLs.
Minimum Requirements:
- Typically, 2 to 5 years’ experience in Global Labelling, Regulatory Affairs, or related pharmaceutical development functions with demonstrated labelling drafting and maintenance experience.
- Working knowledge of core labelling concepts and major market formats (for example CDS, USPI, EU SmPC and PIL) and ability to apply internal standards and regulatory requirements.
- Ability to review and interpret clinical and safety information and translate into clear, consistent labelling text with appropriate referencing.
- Strong attention to detail and documentation discipline (version control, traceability, and rationale).
- Experience organizing and facilitating cross-functional meetings (for example ELTF) and managing actions to closure.
- Strong collaboration, communication, and prioritization skills; proactive issue identification and escalation.Continuous improvement mindset; experience supporting audits and inspection readiness activity
- Science-based BS or MS with demonstrated capability; advanced degree preferred
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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Accessibility and accommodation
Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
