Zion Faye

About Zion Faye

Completed her undergraduate degree (BSc) in Chemistry from the prestigious University of…

Experience

1. Specialist, Regulatory Submission Project Management (Rspm)

   Regeneron

   Sep 2022 — Present

   Managing regulatory milestones from IND Project Approval (IPA) to post marketing, including deliverables such as INDs and amendments, CTAs and amendments, BLAs and amendments/supplements, MAAs and variations in according with applicable Regulatory Agency regulations, guidelines, and/or specifications (e.g, FDA, EMA, ICH etc.) • Maintaining accurate program timelines for cross-reporting with other functional groups • Updating portfolio and management review timelines to help prepare for cross-functional and upper-management discussions • Creating and managing submission timelines and responsibility matrices • Providing guidance to cross-functional groups on routing documents through review and publishing cycles and uploading submission documents to the regulatory submission document management system • Scheduling and manages routine regulatory submissions, such as those for IND safety reports, clinical site documentation updates (1572s), lot releases, promotional pieces • Providing support for monitoring and tracking performance of submission process for clinical site documentation (Form FDA 1572) • Coordinating publications (literature references) for submissions across all programs • Tracking submission deliverables for routine submissions, and provides support in tracking deliverables for larger submissions manages overall completeness of scheduled submissions and coordinates with Regulatory Operations on submission timing, and document status