Job Description
When our values align, there's no limit to what we can achieve.
We are seeking a dedicated Regulatory Affairs Labelling professional to join our growing team! This role offers an opportunity to work with global labelling teams, ensuring regulatory compliance and supporting product labelling management across multiple regions.
The role can be home or office based in various European locations.
Role Responsibilities:
Support Global Labelling, Regulatory (Clinical/Safety), or Medical Writing teams for labelling updates
Manage Company Core Datasheet (CCDS) implementation into labelling and artworks
Identify triggers for CCDS updates and coordinate impact assessments for technical changes
Apply knowledge of Safety Signal Management and its impact on labelling
Navigate CCDS governance processes in pharmaceutical environments
Understand Periodic Safety Update Rep...
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