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Pharmaceutical Labeling Manager

1 week ago

Stockholm, Stockholm, Sweden Sobi - Swedish Orphan Biovitrum AB (publ) Full time
Key Responsibilities

The Global Labeling Operations Lead will be responsible for the following key tasks:

  • 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.
  • Support global labeling management improvement initiatives and participate in the development of SOPs, Work Instructions, and guidance documents.
Required Skills and Qualifications

The ideal candidate will possess the following skills and 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.