Design and Implementation of a Green Light Signal Process for Regulatory PMO Team

Abstract

The Project Management Office (PMO) Regulatory Team, manages regulatory projects that include in the scope all countries globally that can import and distribute their products. The Master Regulatory Schedule (MRS) is prepared with the countries’ outcome to provide visibility to the Franchise and Supply Chain (SC) of the projects that are in the process of being implemented. Challenges for Supply Chain to provide accurate data into the Master Regulatory Schedule and for countries to review the data provide and align dates have been evaluated to identify the risks for restricted countries that cannot receive the previous product after submitting or approving the new product. The main goal is to achieve supply continuity in all countries and avoid any disruptions in product supply by implementing a Green Light Signal. The Project Management Office team started gathering feedback to improve the process, reduce workload, identify priorities, and avoid and mitigate risks. Key Terms ⎯ Green Light Signal, PMO, Restricted countries, Supply Continuity.