

Job Description Summary
#LI-Hybrid (12 days per month on-site if living within 50 miles of our London office)
Job Description
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.
Skills Desired