Regulatory Affairs Consultant - Labelling

Regulatory Affairs Consultant - Labelling

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Responsibilities

• Previous experience working in industry in support of Global Labeling, Regulatory (Clinical / Safety), or Medical Writing for labelling updates
• Use of document management tools (internal systems) and external platforms
• Strong familiarity with the Company Core Datasheet (CCDS) and its implementation into labelling and artworks
• Knowledge of the triggers that lead to a CCDS update, and ability to manage/coordinate impact assessments for technical changes impacting labelling
• Understanding of Safety Signal Management and the impact of confirmed safety signals on labelling
• Familiarity with CCDS governance processes in Pharma Companies
• Some understanding of Periodic Safety Update Reports (PSUR) and potential impact on labelling
• Appreciation of the relationship between labelling and ar...