Regulatory Submissions Associate/Senior Associate (Biological products)

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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