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Novartis

Global Labelling Director, Content – Immunology

Novartis

Global Labelling Director leading development of labelling strategies for innovative medicines in Immunology. Ensuring alignment with regulatory requirements and supporting cross-functional collaboration.

Posted 6/2/2026full-timeLondon • 🇬🇧 United KingdomLeadWebsite

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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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