Senior Regulatory Specialist, Country Labelling Expert

2 tygodni temu

Warszawa, Mazovia, Polska 9605 GSK Services Sp z o.o. Pełny etat

Job Summary:

The Senior Regulatory Specialist, Country Labelling will be responsible for effective coordination, communication, and maintenance of regional/country labelling documents and data in regulatory systems in accordance with defined standards and processes.

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 (including GRA, Global safety and medical, and Local Operating Companies) to author, compile, and deliver quality labelling documents.
  • Support other regulatory functions and participate in other projects and activities as needed.

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 and experience in updating and managing Regional/Country Labeling documents.
  • Knowledge of labelling regulations/requirements in 1 or more regions.
  • Attention to detail, significant experience of document and database management, excellent organization and time management skills.
  • Excellent written and verbal English language communication skills.
  • Ability to think flexibly and meet constantly shifting priorities and timelines.

What We Offer:

  • Career at one of the leading global healthcare companies.
  • Hybrid type of work - 2/3 days per week from the office.
  • Contract of employment.
  • Attractive reward package.
  • Life insurance and pension plan.
  • Private medical package.
  • Sports card.
  • Possibilities of development within the role and company's structure.
  • Personalized learning approach.
  • Extensive support of work-life balance.

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