Global Labelling Associate Director, Content (Established Products)
Remote · London, England, United Kingdom or United Kingdom
Job Summary
Global Labelling Associate Director, Content (Established Products) develops and maintains global labelling strategies and core documents (e.g., CDS; USPI; EU SmPC/PIL) for assigned products, leads cross-functional discussions to align labelling content and strategy, analyzes regulatory guidance and competitor labelling to inform content, prepares responses to Health Authority queries, collaborates with global/regional partners to ensure consistency across markets, mentors colleagues, and supports audit readiness and inspections. The role requires interpreting clinical efficacy and safety data into clear, compliant labelling content, with working knowledge of major Health Authority requirements, and fluency in English. Office location is London (The Westworks), UK with hybrid on-site requirements (#LI-Hybrid) and remote options (#LI-Remote for those living farther than 50 miles). Novartis emphasizes diversity, inclusion, and a fraud-awareness message within the posting.
Required Qualifications
- 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
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