At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver creative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.
Position Summary
The role is to provide coordination and operational support to cross-functional regulatory teams and Country Regulatory to ensure regulatory portfolio deliverables are delivered to plan and in compliance with global processes and appropriate local regulatory requirements.
Position Responsibilities:
Responsibilities include but not limited to:
• SharePoint Maintenance Activities; Support GRT member transition by setting up transition form (operational)
Execution of Regulatory Strategy
• Liaise cross-functionally to generate periodic internal milestone report
Regulatory Intelligence
• Performs simple analyses as directed
Global Regulatory Submissions Support
• Support planning and managing timely deliverable of critical regulatory deliverables (registration samples) and various Module 1 documents for ex-US,ex-EU countries
• Request certificates from respective Health Authority (FDA, EMA, Swiss Medic) and manage notification process
• Shipping of documents, as required
• Admin- scanning, copying, shipping label
Support of Divestitures / Product Deletions / Product Termination / Asset Integration
• Product Divestiture: Upload relevant documents into the Virtual Data Room (VDR) for potential buyers
• Product Deletions: Gather information from the Country Regulatory Managers for Product Deletions Strategy