Associate GRAAS Operations

Role -GSIM Regulatory Data Management - Associate

Organization -​​Global Regulatory Affairs Execution Team​

Group Purpose -Ensure the smooth compliant flow of information between all Functional areas, internal and external to GRAAS, local offices, externalpartnersand regulatory authorities.

Job Summary

•Monitoring data quality/health, including collaboration with other internal functions tomaintainplanned submission and approval dates

•Integrations: 

•Updating the Regulatory Submissions and Document Information Management System (RSDIMS) and Analytics: 

•Metrics compilation and analysis 

•Liaison with internal customers to improve efficiencies within RDA and other functional areas

•Manages requests within the Regulatory Intake System tocomply withdata management of a GMP system

Key Activities

•MaintainRegulatory document management and tracking systems 

•Create/archive Clinical Trial and Marketing Application submissions/Health Authority correspondence

•Responsible formaintainingthe on-site hard copy Regulatory archive and overseeing incoming/outgoing off-site Regulatory document storage

•Point of contact between Regulatory Representatives/CMC and publishing teams

•Manage the Protocol Amendment New Investigator (PANI) submissions and PI updates/additions

•Ensuring Regulatory compliance with SOPs and Regulatory authorities

•Provide support to RDA team members and other functional areas, including vendors

•Collaboration with external partners/outsourced CROs

•Manage 1572 forms for FDA submission