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, external partners and regulatory authorities. 

Job Summary 

• Monitoring data quality/health, including collaboration with other internal functions to maintain planned 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 to comply with data management of a GMP system 

Key Activities 

• Maintain Regulatory document management and tracking systems  

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

• Responsible for maintaining the 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