- Successfully managed 10 simultaneous global Marketing Applications (MA) to 9 regions/countries for dengue vaccine (submitted 1 day early with zero validation errors)
- Product Owner for Regulatory Information Management (RIM) Product Team that successfully deployed multiple releases using Agile methodology in a GxP environment
- Established a first-in-class cloud-based RIM system (Electronic Document Management System [EDMS], Registrations and Archive) that provides a comprehensive solution for creating, managing, and tracking regulatory documents and information
- Developed 4 on-demand, in-depth and interactive eLearning training modules delivering a total of 5.5 hours of focused content designed from an end-user perspective
- Optimized submission publishing process resulting in a reduction of routine publishing lead time from 5 to 2 days
- Instituted global submission document preparation process that incorporates submission-ready standards, use of EDMS and access to leverage document support resources
- Transitioned IND submission portfolio from paper to eCTD
- Centralized regulatory archives (paper and electronic)
