Senior Regulatory Specialist

3 tygodni temu


Poznań, Greater Poland 9605 GSK Services Sp z o.o. Pełny etat
Job Summary

As a Senior Regulatory Specialist - Country Labelling, you will be responsible for effective coordination, communication, and maintenance of regional/country labelling documents and data in regulatory systems.

Key Responsibilities
  • Author and compile Regional/Country Product Information as per regulatory authority labelling requirements and GSK process and standards.
  • Author and compile market-specific supporting documentation for labelling submissions in accordance with regulatory authority requirements and GSK process and standards.
  • Provide support to global and local GRA team members through preparation of other labelling documents as required.
  • Complete quality and consistency checks of labelling document content.
  • Efficiently coordinate and manage labelling documentation and data in regulatory systems.
  • Provide advice regarding regulatory authority labelling requirements and GSK labelling process and standards to GRA global/local roles and via Regulatory Matrix Teams.
  • Effectively communicate with GSK staff to author, compile, and deliver quality labelling documents.
  • Support other regulatory functions and participate in other projects and activities as needed.
  • Subject Matter Expert in country/regional labelling content and process for markets with complex labelling requirements.
Requirements
  • Relevant experience in the pharmaceutical industry, life sciences research, or regulatory.
  • Masters degree in Science or Life Sciences.
  • Successfully performed within a regulated or quality-critical environment.
  • Understanding of labelling regulations and requirements.
  • Experience in updating and managing Regional/Country Labelling documents.
  • Knowledge of labelling regulations/requirements in 1 or more regions (EU preferred).


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