Manager, Regulatory Affairs Project Management
Core
Plan, execute, and drive regulatory submissions (INDs, NDAs, CTAs, etc.) and manage cross-functional timelines for oncology radiopharmaceutical therapies.
Role type
Manager, Regulatory Project Management
Builds
Regulatory submission packages and briefing materials for oncology radiopharmaceuticals
Domain
Life Sciences / Oncology / Radiopharmaceuticals
Required skills
Regulatory submission planning, cross-functional coordination, risk management, documentation, MS Project/Smartsheet, global regulations knowledge, oncology development experience
Preferred skills
NDA filing experience, radiopharmaceutical experience, AI application for team execution
Technologies
MS Project, Smartsheet, MS Office
Responsibilities
Lead planning and execution of regulatory submissions; Develop and manage detailed regulatory project timelines; Monitor project progress and escalate risks; Serve as primary project management point of contact; Prepare regulatory submission trackers and dashboards
Seniority
Manager, hands-on IC