Job Description Summary
#LI-Hybrid (12 days per month on-site if living within 50 miles of our London office)Job Description
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 benefitrisk 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 paragraph
Novartis is committed to building an outstanding inclusive work environment and diverse teams representative of the patients and communities we serve.
Skills Desired
Required Experience:
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