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