Global Labeling Operations Specialist

1 day ago


Stockholm, Stockholm, Sweden Sobi Full time
Job Description

Sobi offers the opportunity to work at an international pharmaceutical company focused on specialty pharmaceuticals meeting the high medical needs of rare disease patients and providing treatment and services to them.

Key Responsibilities:
  • Coordinate labeling projects to ensure timely delivery of print-ready packaging and labeling documents.
  • Manage EU labeling readability testing and translation activities with vendors and oversee affiliate review of EU SmPC translations during linguistic review.
  • Develop regulatory content for printed labeling components (e.g., carton and container) for EU and/or US submissions.
  • Serve as a liaison to external vendors regarding the creation, review, and submission of US Structured Product Labeling (SPL) content.
Requirements
  • 5+ years of experience in Labeling Operations within the pharmaceutical industry.
  • Experience working in a global environment.
  • Strong track record of leading projects and collaborating effectively in cross-functional teams.

Desirable Skills/Knowledge:

  • Strong knowledge of EU and/or US labeling regulations and guidance.
  • Proficiency in working with electronic document management systems (e.g., Veeva), as well as the MS-Office Suite and Adobe Acrobat.
  • Fluency in English, additional language skills are a plus.


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