The Senior Program Manager will coordinate delivery operations across the MarTech organization, managing integrated planning, cross-functional dependencies, and stakeholder communications. They will also support portfolio governance, release readiness, and the implementation of marketing technology initiatives.
The CMC Manager will support global regulatory CMC strategies for drug-device combination products and prepare regulatory documentation for submissions. They will collaborate with cross-functional teams to ensure compliance with global regulatory requirements and design controls.
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.
