Remote Regulatory affairs Jobs • ECTD

This role supports data mapping of eCTD metadata from our legacy publishing system into our future state system and supporting activities in preparation of enabling eCTD 4.0 submissions. The project work will mostly be conducted in Excel, working against data extracts from Veeva Vault RIM and requires a deep understanding of eCTD structure, metadata and organization as well as experience with Veeva Vault RIM.

Praxis's Regulatory team is seeking a Consultant for approximately 7-8 months, specifically a Senior Regulatory Submissions Manager to oversee the operational aspects of submissions to U.S. and international Regulatory Agencies. They will manage the planning, tracking, coordinating, compiling, QC, submitting, and archiving of submissions in order to ensure the submissions are of the highest quality and delivered on-time.