Manager, Project Management, Regulatory

Coordinate day-to-day project activities across cross-functional teams, including Research, CMC, Quality, Regulatory Affairs, Clinical Operations, and external partners. Develop and maintain project timelines, action-item trackers, meeting agendas, and other key project documentation. Schedule and facilitate project team meetings, prepare meeting minutes, and follow up on action items to support timely completion. Monitor project progress and promptly escalate potential risks, delays, and resource constraints to project leadership. Support the preparation and coordination of activities related to Investigational New Drug (IND) submissions and other regulatory filings. Track project budgets, purchase orders, invoices, and resource utilization in collaboration with Finance and functional leads. Assist with preparation of project dashboards, presentations, reports, and materials for leadership reviews, governance meetings, and investor or partner updates. Assist with onboarding new project team members by coordinating access to systems, project documentation, and team resources. Provide general administrative support to the cross function as needed. Support vendor onboarding, contract routing, purchase requisitions, and invoice processing in partnership with Procurement and Finance. Facilitate clear, effective communication among internal stakeholders and external collaborators, including contract research organizations (CROs) and contract development and manufacturing organizations (CDMOs). Ensure project documentation is accurate, well organized, and maintained in accordance with company procedures. Contribute to the continuous improvement of project management processes, templates, and best practices.