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Global Labelling Associate Director, Content – Cardiovascular, Renal & Metabolism
NovartisGlobal Labelling Associate Director tasked with developing global labelling strategies for Cardiovascular, Renal & Metabolism products. Collaborating with cross-functional teams to ensure compliant and competitive product information.
About the role
Key responsibilities & impact- 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.
Requirements
What you’ll need- 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.
Benefits
Comp & perks- Commitment to Diversity and Inclusion / EEO paragraph
- Health insurance
- Retirement plans
- Paid time off
- Flexible work arrangements
- Professional development
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Global LabellingGlobal Regulatory Affairscore labelling documentsCDSUSPIEU SmPCPILclinical efficacy data interpretationsafety data interpretationcompliance
Soft Skills
collaborationcommunicationfacilitationplanningprioritisationattention to detailmentoringcross-functional discussion supportrisk assessmentcontinuous improvement