Senior Regulatory Specialist, Country Labeling and Compliance

1 miesiąc temu

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

We are seeking a highly skilled Senior Regulatory Specialist, Country Labelling and Compliance to join our team at 9605 GSK Services Sp z o.o. This role is 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:

  • Coordinate and manage labelling documentation and data in regulatory systems.
  • 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.
  • Effectively communicate with GSK staff to author, compile, and deliver quality labelling documents.
  • Advise on regulatory authority labelling requirements and GSK labelling process and standards.
  • 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/requirements in 1 or more regions.
  • Attention to detail, document and database management experience, excellent organisation and time management skills.
  • Excellent written and verbal English language communication skills.
  • Ability to think flexibly and meet shifting priorities and timelines.

What we offer:

  • Hybrid work arrangement with 2/3 days per week from the office.
  • Contract of employment.
  • Attractive reward package.
  • Life insurance and pension plan.
  • Private medical package and preventive healthcare services.
  • Sports card and development opportunities.

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