Summary
12 days per month on-site if living within 50 miles of our London office. Homeworker if living further. Office Location: London (The Westworks), United Kingdom.
Major Accountabilities
* Lead the development of global labelling content strategies for assigned products, ensuring alignment with the Target Product Profile and broader asset strategy.
* Develop and maintain core labelling documents and major market labels (e.g. CDS, USPI, EU SmPC/PIL).
* Contribute to defining key product claims, ensuring clarity, scientific integrity, and compliance.
* Collaborate with cross-functional teams (Regulatory, Clinical, Safety, Medical, Commercial) to enable alignment on labelling strategy and content.
* Contribute to, and where appropriate, lead interactions with Health Authorities, supporting evidence‑based and compliant outcomes.
* Monitor competitor intelligence, regulatory trends, and evolving guidance to inform labelling strategy.
* Support the development of robust evidence packages and associated regulatory documentation.
* Represent global labelling in governance forums and contribute to decision‑making discussions.
* Support knowledge sharing, mentoring, and continuous improvement within the labelling community.
Essential Requirements
* Fluency in English (written and spoken).
* Demonstrated capability in Global Labelling and/or Global Regulatory Affairs, with a strong focus on labelling across development and lifecycle stages.
* Ability to lead labelling strategy for complex assets, shaping key claims and supporting alignment across governance forums.
* Strong understanding of drug development, benefit–risk, and safety, with the ability to translate clinical data into clear, compliant labelling content.
* Working knowledge of global labelling standards and major Health Authority expectations, including development and maintenance of core and major market labelling.
* Ability to lead and influence cross‑functional teams within a global matrix environment.
Commitment to Diversity and Inclusion / EEO
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Benefits and Rewards
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