Regulatory

  • location: Swiftwater, PA
  • type: Contract
  • salary: $39.28 - $46.21 per hour

job description

Regulatory

Job Title: Regulatory Affairs Specialist V

Job Summary

  • The worker will support Global Regulatory Team Leaders (GRTL) in their activities in the GRA GBU Flu and INPM Franchises. Will perform a variety of functions including: different types of activities related to several products with mainly US and EU scope but also Canada and ROW (Australia and Brazil) scope
Job Responsibilities

  • Lifecycle maintenance activities: coordination of labeling variations preparation
  • Support in HA meeting preparation and documentation(minutes) : preBLA meeting, EMA Scientific advice
  • CTD dossier completion
  • Regulatory strategic document preparation for an early development stage product
  • Support in GRT organizational aspects
  • SHAREpoint organization/maintenance, dashboards, action follow-up
  • Support in consolidating various global information relevant for products or portfolio
  • Support for preparation of Briefing Packages or other submission components, as necessary
  • Support for preparation and maintenance of document inventory for core dossier preparation (= Product Reference File)
  • Support for preparation of documentation for various governance committees and related documents
  • Support for monitoring of global submissions/approvals status, global oversight of Health Authority commitments, and contribute to Key Performance Indicators (KPI) monitoring
  • Support for preparation of regulatory information for Periodic Benefit-Risk Evaluation Reports (PBRERS) and Development Safety Update Reports (DSURs)
Education & Qualifications

  • Bachelor's required; advanced degree preferred
  • Preferably a MSc in Biology, Life Science, or related field of study with 5-10 years of prior Regulatory Affairs experience
  • Knowledge of microbiology, immunology, virology or bacteriology would be a plus
  • Organizational and communication skills
Benefits

  • Medical, Dental, and Vision Insurance
  • 401K Plan with Company Match
  • Life and AD&D Insurance

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