Global Labelling Director, Content

• 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 benefitrisk 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.