Manager, Regulatory Affairs Project Management
Core
Lead planning, coordination, and execution of global regulatory submissions (INDs, NDAs, CTAs) for oncology radiopharmaceutical therapies.
Role type
Manager, Regulatory Project Management
Builds
Regulatory submission packages and briefing materials for clinical and nonclinical programs
Domain
Oncology / Radiopharmaceuticals / Life Sciences
Deliverable
production ML models | product features | dashboards & analysis | client delivery | infrastructure | physical/clinical work
Required skills
Regulatory submission lifecycle management, cross-functional stakeholder coordination, risk identification and mitigation, project timeline development, documentation and reporting, global regulatory standards knowledge, oncology development program support, radiopharmaceutical experience, AI application for team execution
Preferred skills
NDA filing experience, Gantt chart software proficiency (MS Project, Smartsheet)
Technologies
MS Project, Smartsheet, MS Office (Outlook, Word, PowerPoint, Excel, Teams)
Responsibilities
Lead planning and execution of regulatory submissions (INDs, amendments, CTAs, NDAs, MAAs, IMPDs, briefing packages, RFIs); Develop and maintain detailed regulatory project timelines; Monitor project progress and escalate risks with mitigation strategies; Serve as primary point of contact for assigned submissions; Prepare regulatory submission trackers and project dashboards; Document key milestones, decisions, and action items
Seniority
Manager, hands-on IC