Position Responsibilities

• In close partnership with the regional strategists / liaisons and/or GRL Team leader, develop strategic and operational plan for the development and the registration of assets across the Therapy Area.
• Lead development of strategy and content for U.S. dossier in partnership with marketing application submission teams for indications that are at the regulatory filing stage.
• Develop contingency plans in conjunction with the GRL or Team Leader to achieve regulatory objectives, identifying risks and proposing mitigation strategies in collaboration with GRT.
• Develop and execute approaches to resolve regulatory issues and drive speed to patients.
• Develop predictions for expectations and risks associated with outcomes by regulatory agencies; identify regulatory risks and propose mitigations to senior leaders and cross‑functional teams.
• Lead and/or support global health authority interactions by preparing...