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Global Labelling Director, Content – Immunology
NovartisGlobal Labelling Director leading development of labelling strategies for innovative medicines in Immunology. Ensuring alignment with regulatory requirements and supporting cross-functional collaboration.
About the role
Key responsibilities & impact- 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.
Requirements
What you’ll need- 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.
Benefits
Comp & perks- Commitment to Diversity and Inclusion / EEO paragraph
ATS Keywords
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Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Global LabellingGlobal Regulatory Affairslabelling strategycore labelling documentsmajor market labelsregulatory documentationevidence packagesdrug developmentclinical data analysiscompliance
Soft Skills
leadershipcollaborationcommunicationmentoringinfluencestrategic thinkingproblem-solvingcross-functional teamworkdecision-makingcontinuous improvement