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

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Global LabellingGlobal Regulatory Affairslabelling strategycore labelling documentsmajor market labelsregulatory documentationevidence packagesdrug developmentclinical data analysiscompliance

Soft Skills

leadershipcollaborationcommunicationmentoringinfluencestrategic thinkingproblem-solvingcross-functional teamworkdecision-makingcontinuous improvement

Industry Keywords

Target Product ProfileHealth AuthoritiesCDSUSPIEU SmPCPILbenefit-risksafetyregulatory trendsgovernance forums

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