Deborah Cunningham

Director of Regulatory Operations @Vericel® Corporation

US

Oversee and maintain the structure of the RIM system to ensure adequate storage, security, and retrieval of regulatory documents. • Develop and maintain metrics and KPI for the Regulatory function• Oversee and maintain AI tool kit for the Regulatory function. Assess needs and onboarding on Ai agents• Ensure FDA requirements for regulatory document retention are met.• Work with internal and/or external resources to manage the submissionprocesses that will allow document authoring, version control, and links to other documents.• Oversee the publishing and electronic submission to FDA and other regulatory agencies.• Project manage the planning, tracking and preparation of technically compliant submissions to achieve FDA and Corporate timelines. Dashboarding and tracking in Smartsheets.• Work effectively with cross-functional teams in the planning, tracking and preparation of regulatory submissions.• Contribute to the development of regulatory processes, procedures, and systems to support functional area growth.• Work closely with IT business partners on all aspects of regulatory system management.• Lead and develop internal regulatory operations staff and manage external vendor relationships • Manage Vendor engagement, contracts • Financial tracking, forecasting and reporting for the Regulatory function

University of Costa Rica

BSc, Chemisty-

King's College London

MSc, Quality Control & Pharmaceutical Analysis with minor on PK/ADME and Pharmaceutical Technology