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Regulatory Systems and Metrics Analyst, Warsaw

1 miesiąc temu

Warszawa, Mazovia, Polska TN Poland Pełny etat
Regulatory Systems and Metrics Analyst

This is a highly impactful regulatory affairs role that allows you to shape and accelerate regulatory effectiveness across the organization.

You will be responsible for supporting strategic and operational regulatory projects that align with business strategy and platform delivery.

Key responsibilities include:

  • Fulfilling standard, ad hoc, or complex data reporting requests and designing outputs.
  • Assisting Regulatory Business Operations (RBO) staff in delivering projects.
  • Assisting RBO staff in documenting, monitoring, and reporting processes.
  • Maintaining Team sites, adhering to records retention.
  • Assisting Regulatory Business Operations staff in optimizing project plan robustness (scope, deliverables, resources, timing).
  • Providing project support to meet assigned business deliverables.
  • Editing existing process documentation and leading monitoring and reporting.
  • Providing analysis and interpretation of information in response to requests from requestors and pursuing greater data quality through identification of gaps and delivery of efficient solutions.

Required qualifications include:

  • Bachelor's degree in a scientific field.
  • 3 years of experience in the pharmaceutical industry within a regulatory environment.
  • Comfort with GXP system validation and maintaining system compliance.
  • Experience with License Maintenance as well as overall R&D processes.
  • Direct experience in project planning and execution.
  • Advanced proficiency in Excel, Power Queries, and Power BI reporting.
  • Experience working in a matrix environment and the ability to engage and influence senior stakeholders will be considered an asset.