Job Description

The opportunity

  • Ensure the pharmaceutical, medical, and regulatory accuracy of English product information (SmPC, Labeling, PIL) for European procedures (MRP, DCP, CP) of innovative, biosimilar and generic products.
  • Provide internal pharmaceutical and medical expertise to address internal and authority-related inquiries and resolve labeling issues.
  • Ensure regulatory compliance for all maintained innovative, biosimilar and generic EU procedures (MRP, DCP, CP) regarding labeling.
  • How you’ll spend your day

  • Labeling
  • Responsible for creating and updating compliant English product information for EU procedures.
  • Strategic planning and implementation of changes affecting multiple product information documents.
  • Determination of an implementation plan and tracking the implementation of updates due to new requirements (e.g. new excipients warnings, QRD template update). ...
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