Regulatory Specialist, Portfolio Acceleration and Analytics

Tasks

• Build monthly dashboards
• Communicate regulatory timelines
• Create response templates
• Gather information for product deletions strategy
• Generate periodic internal milestone reports
• Maintain SharePoint activities
• Manage health authority notifications
• Perform simple regulatory analyses
• Plan and manage regulatory deliverables
• Prepare GRS analytics
• Prepare Module 1 documents
• Prepare registration samples
• Remediate documents
• Request certificates from health authorities
• Scan copy and apply shipping labels
• Schedule regulatory review team meetings
• Ship regulatory documents
• Submit responses for publishing
• Support GRT member transition
• Track product deletion notifications
• Update document metadata
• Upload documents into Virtual Data Room
• Upload incoming documents to BMS systems

Perks/Benefits

• N/A

Skills/Tech-stack

Analytics | Clinical Regulatory | Clinical Regulatory Intelligence | Dashboard Reporting | Data Room | Document Management | Metadata Management | Regulatory Affairs | Regulatory Intelligence | Regulatory Submissions | SharePoint