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Global Regulatory Specialist

2 tygodni temu

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

We are looking for a talented Regulatory Affairs Submissions Specialist to join our team at ManpowerGroup Sp. z o.o.

About the Role

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.

Key Responsibilities
  1. Create and manage the Dossier Plan(s)/Submission Packages in line with regulatory strategy, providing guidance to project team members.
  2. Ensure that all required documents are included in the Dossier/Submission Package.
  3. Perform a dossier review of the published output.
  4. Track submission events/activities and timelines in appropriate systems/tools.
  5. Lead submission team meetings, as applicable, working with partners to resolve issues with time lines.
  6. Monitor the effectiveness of the dossier process to identify improvement opportunities.
  7. Lead and/or participate in special projects and process improvement initiatives, as needed.
Qualifications
  • 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.
About Us

ManpowerGroup Sp. z o.o. is a global leader in the staffing industry, operating in 82 countries and employing over 400,000 people worldwide.