Global Labeling Strategist

16 hours ago


Stockholm, Stockholm, Sweden TN Sweden Full time

Job Overview:

The Global Labeling Operations Lead is a critical role that supports the development and maintenance of printed labeling components.

This position will work closely with the Global Regulatory Affairs team to coordinate and manage activities related to labeling artwork lifecycle management, regulatory requirements, and EU labeling readability testing.

Responsibilities:

  • Manage labeling and packaging artwork projects affecting multiple products to ensure timely delivery.
  • Coordinate labeling artwork lifecycle management in collaboration with the Regulatory Strategy Leads and Labeling Operations Coordinators.
  • Provide expertise to cross-functional teams and external vendors regarding regulatory requirements for the development of printed labeling components.
  • Review and approve mock-ups and artworks to ensure compliance and timely delivery of print-ready packaging and labeling documents.
  • Coordinate EU labeling readability testing and translation activities with vendor and oversee affiliate review of EU SmPC translations during linguistic review.
  • Manage EU SmPC master documents in the Veeva Regulatory Information Management (Veeva RIM) system during product labeling life cycle.
  • Collaborate with Global Strategic Labeling Leads to support the delivery of submission-ready EU and US labeling documents.
  • Serve as a liaison to external vendor regarding the creation, review and submission of US Structured Product Labeling (SPL) content.
  • Support global labeling management improvement initiatives and participate in the development of SOPs, Work Instructions, and guidance documents.

Qualifications:

  • 5+ years of experience in Labeling Operations within the pharmaceutical industry.
  • Experience in developing regulatory content for printed labeling components (e.g., carton and container) for EU (MAA/variations) and/or US (NDA/BLA) submissions; experience with additional regions/countries is a plus.
  • Experience working in a global environment.
  • Strong track record of leading projects and collaborating effectively in cross-functional teams.


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