Regulatory Operations Lead

4 days ago


Stockholm, Stockholm, Sweden Sobi Full time

Sobi seeks a highly skilled Regulatory Operations Lead to oversee labeling compliance and regulatory strategy.

Job Description

The successful candidate will be responsible for managing labeling operations, ensuring timely delivery of print-ready packaging and labeling documents, and collaborating with cross-functional teams.

  • Develop and implement regulatory content for printed labeling components for EU and/or US submissions.
  • Coordinate labeling artwork lifecycle management with Regulatory Strategy Leads and Labeling Operations Coordinators.
  • Provide expertise on regulatory requirements for printed labeling components to external vendors and internal teams.
Key Responsibilities
  • Manage EU SmPC master documents in the Veeva Regulatory Information Management system.
  • Coordinate EU labeling readability testing and translation activities with vendors.
  • Support global labeling management improvement initiatives.
Requirements
  • 5+ years of experience in Labeling Operations within the pharmaceutical industry.
  • Strong knowledge of EU and/or US labeling regulations and guidance.
  • Proficiency in electronic document management systems and MS-Office Suite.


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