Global Labelling Associate Director, Content (Cardiovascular, Renal & Metabolism)

Overview

Global Labelling Associate Director, Content (Cardiovascular, Renal & Metabolism) located London. 12 days on site if within 50 miles of the London office, otherwise remote. Contribute to global labelling strategies across the product portfolio.

Responsibilities

• Develop and maintain global labelling strategies and documents (e.g., CDS, USPI, EU SmPC/PIL).
• Lead cross‑functional discussions to align on labelling content and strategy.
• Present labelling proposals and updates to governance bodies and project teams.
• Identify emerging labelling considerations, contributing to planning, risk assessment, and mitigation strategies.
• Analyse competitor labelling, regulatory guidance, and scientific data to inform content development.
• Support 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 support audit readiness, inspections, and continuous improvement initiatives.

Qualifications

• Fluency in English (written and spoken).
• Demonstrated capability in Global Labelling and/or Global Regulatory Affairs, focused on labelling across development and lifecycle activities.
• Ability to develop and maintain core labelling documents (e.g., CDS) and support major market labelling with scientific accuracy and compliance.
• Ability to interpret clinical efficacy and safety data and translate 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, facilitating cross‑functional discussions and supporting alignment.
• Strong planning, prioritisation, and attention to detail to deliver high‑quality work within timelines.

EEO / Diversity

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

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