Senior Regulatory Professional

5 dni temu


Warszawa, Mazovia, Polska TN Poland Pełny etat
Job Overview

The Senior Regulatory Specialist, Country Labelling is a key role within TN Poland, responsible for ensuring the effective coordination, communication, and maintenance of regional/country labelling documents. This position requires strong leadership skills to provide support to global and local GRA team members.

Key Responsibilities:
  • Authoring and compiling Regional/Country PI as per regulatory authority labelling requirements and GSK process and standards.
  • Providing advice regarding regulatory authority labelling requirements and GSK labelling process and standards to GRA global/local roles and via Regulatory Matrix Teams.
  • Serving as Subject Matter Expert in country/regional labelling content and process for markets with complex labelling requirements.

Requirements:

  • Relevant experience (in pharmaceutical industry, life sciences research or regulatory).
  • Masters degree Area of Specialisation: Science or Life Sciences (must have).
  • Successfully performed within a regulated or quality-critical environment (such as pharmaceutical industry research, pharmacy, safety or regulatory).


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