Senior Regulatory Affairs Manager (Labeling) | Senior Regulatory Affairs Manager (Labeling)- FSP

Job Summary

This Senior Regulatory Affairs Manager role focuses on managing global labeling activities and ensuring strict compliance with international regulatory standards, specifically within the biotech/pharmaceutical sector. The specialist coordinates all aspects of the labeling lifecycle across foundational markets (EU, CH, DE) and dependent markets, including preparation, submission, maintenance, and linguistic review of labeling documents. Key responsibilities involve managing internal systems (Documentum, Veeva, Trackwise), maintaining core documents (CCDS, USPI, SmPC), leading Global Labeling Committee evaluations, and ensuring compliance with FDA-508 and annual reporting requirements. The ideal candidate requires extensive experience in regulatory labeling, a comprehensive understanding of US, EU, and other major market regulations, and the ability to lead cross-functional initiatives and provide strategic input to therapeutic area teams. This position is critical for ensuring the accuracy and timely implementation of life-changing therapies globally.