Senior Manager, International Regulatory Project Manager

Job Summary (Primary function)

The International Regulatory Project Manager is responsible for planning, managing, and tracking the regulatory portfolio of international submissions for assigned programs. This role will be responsible for maintaining comprehensive plans, timelines, and submission deliverables for all major milestones and maintenance activities related to the filings, including the gap analysis process with local regulatory experts (partners) and submission content plans. This role will be responsible for facilitating timeline risk mitigation and contingency planning. This role will work with the regulatory team and key functions to maintain the latest dates, understand the change drivers, update the plan and keep stakeholders informed.

The International Regulatory Project Manager works in collaboration with multiple members of the regulatory and TechOps teams managing the submission planning (timelines), execution, and implementation throughout the...