The manager is responsible for the planning and execution of international regulatory CMC submissions and lifecycle management for marketed products. They provide regulatory support to cross-functional teams and ensure product compliance regarding change controls and GMP investigations.
Support the execution of regulatory CMC strategies for marketed cell and gene therapy products. This includes planning and preparing international regulatory submissions and providing guidance to cross-functional teams on product compliance.
The role involves eliciting and translating business requirements into system enhancements for Veeva Vault RIM to optimize regulatory operations. The analyst will serve as a functional SME, managing data models, system integrations, and reporting dashboards to support Global Regulatory Affairs.
