Global Labelling Associate Director, Content (Established Products)

Major Accountabilities

• Develop and maintain global labelling strategies and core labelling documents for assigned products (e.g. CDS, USPI, EU SmPC/PIL).

• Lead and facilitate cross-functional discussions to support alignment on labelling content and strategy.

• Present labelling proposals and updates to governance bodies and project teams

• Identify emerging labelling considerations and contribute to planning, risk assessment, and mitigation strategies.

• Analyse competitor labelling, regulatory guidance, and scientific data to inform content development.

• Support and contribute to responses to Health Authority queries and interactions, including preparation of supporting documentation.

• Collaborate with global and regional partners to ensure consistency and alignment across markets.

• Mentor colleagues and contribute to audit readiness, inspections, and continuous improvement initiatives.

Essential Requirements

• Fluency in English (written and spoken).

• Demonstrated capability in Global Labelling and/or Global Regulatory Affairs, with a focus on labelling across development and lifecycle activities.

• Ability to develop and maintain core labelling documents (e.g. CDS) and support major market labelling (e.g. USPI, EU SmPC/PIL) with scientific accuracy and compliance.

• Ability to interpret clinical efficacy and safety data and translate it into clear, consistent labelling content and supporting documentation.

• Working knowledge of global labelling standards and expectations, including major Health Authority requirements.

• Strong collaboration and communication skills, with the ability to facilitate cross-functional discussions and support alignment.

• Strong planning, prioritisation, and attention to detail to deliver high-quality work within timelines.

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.