About the Role
Major Accountabilities
- Lead the development of global labelling content strategies for assigned products, ensuring alignment with the Target Product Profile and broader asset strategy.
- Develop and maintain core labelling documents and major market labels (e.g. CDS, USPI, EU SmPC/PIL).
- Contribute to defining key product claims, ensuring clarity, scientific integrity, and compliance.
- Collaborate with cross-functional teams (Regulatory, Clinical, Safety, Medical, Commercial) to enable alignment on labelling strategy and content.
- Contribute to, and where appropriate lead, interactions with Health Authorities, supporting evidence-based and compliant outcomes.
- Monitor competitor intelligence, regulatory trends, and evolving guidance to inform labelling strategy.
- Support the development of robust evidence packages and associated regulatory documentation.
- Represent global labelling in governance forums and contribute to decision-making discussions.
- Support knowledge sharing, mentoring, and continuous improvement within the labelling community.
Essential Requirements
- Fluency in English (written and spoken).
- Demonstrated capability in Global Labelling and/or Global Regulatory Affairs, with a strong focus on labelling across development and lifecycle stages.
- Ability to lead labelling strategy for complex assets, shaping key claims and supporting alignment across governance forums.
- Strong understanding of drug development, benefit–risk, and safety, with the ability to translate clinical data into clear, compliant labelling content.
- Working knowledge of global labelling standards and major Health Authority expectations, including development and maintenance of core and major market labelling.
- Ability to lead and influence cross-functional teams within a global matrix environment.
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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