Position Overview
The Regulatory Submission Coordinator – Associate/ Sr Associate level - supports the execution and coordination of regulatory submission and labeling activities across assigned countries within a region.
Reporting to the Regional Submission Coordinator (Lead), this role focuses on operational delivery, documentation coordination, system updates, and labeling execution to ensure timely, compliant, and high-quality regulatory submissions.
The Associate works in close collaboration with the Lead, Regional Regulatory Leads (RRLs), Local Regulatory Responsible (LRRs), Regulatory Partner Representatives (RPRs), and cross-functional stakeholders.
Key Responsibilities
Submission Coordination & Operational Support
Support the coordination, preparation, and delivery of regulatory submissions and lifecycle management (LCM) activities in accordance with submission strategies defined by the RRL and coordinated by the Regional Submission Coordinator (Lead...