Partner with Regulatory leads to manage regulatory filing sub teams and sub team operations, including the coordination, prioritization, and tracking of regulatory activities associated with development and post-marketing activities
Develop and maintain high level and detailed regulatory timelines that utilize project management software tools, with input from functional leads, cross-functional teams, and senior management, assuring that regulatory timelines are aligned with global program strategies
Resolve submission execution issues by managing contingency plans with cross-functional stakeholder input and resolving delays or potential delays
Track functional submission milestones (Regulatory, CMC, Clinical, Nonclinical) and regulatory / submission team activities to ensure overall adherence to timelines
Identify risks and mitigation strategies as well as opportunities for consistency and ef...