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Regulatory Affairs Specialist V
Ref No.: 18-08866
Location: Swiftwater, Pennsylvania
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:
- 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)

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