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Submission Expert

1 tydzień temu

Warszawa, Mazovia, Polska ManpowerGroup Sp. z o.o. Pełny etat

We are seeking a highly skilled Regulatory Affairs Submissions Specialist to support our client specialized in pharma industry.

About the Client

The client is a global leader in the pharma industry, with a presence in over 70 countries and a portfolio of products that includes both prescription and over-the-counter medications.

Job Summary

The Regulatory Affairs Professional Submission Specialist will be responsible for ensuring compliance with regulatory agency regulations and interpretation, coordinating and compiling medium to complex dossier plans/submission packages, and may publish/dispatch.

Main Responsibilities
  • Collaborate with colleagues to ensure compliance with regulatory agency regulations and interpretation.
  • Coordinate and compile medium to complex dossier plans/submission packages.
  • May publish/dispatch.
  • Provide guidance to project team members.
  • Ensure that all required documents are included in the Dossier/Submission Package.
  • Perform a dossier review of the published output.
  • Track submission events/activities and timelines in appropriate systems/tools.
Requirements
  • In-depth understanding of the product development process.
  • Degree in pharmacy, bioscience or similar fields would be an asset.
  • Experience in in regulatory, medical, or pharmaceutical fields, or a background in information/library science.
  • Effective interpersonal, teamwork, and communication skills.
  • Ability to work or lead in a matrix environment.
  • Fluency in English.
  • Proficient use of Regulatory Information Systems, planning, and publishing tools.
What We Offer

We offer:

  • Opportunity to join a global team and work on global innovative projects.
  • Option for 100% remote job within Poland.
  • Work mainly in English within an international team.
  • Attractive salary.
  • ManpowerGroup Benefit Package: healthcare, sports card, possibility of joining group insurance, professional development program.