Manager, Regulatory Submission Management
Core
Partner for strategic planning and execution of the global regulatory submission portfolio to ensure scalability and optimization of filings for new therapies.
Role type
Manager, Regulatory Submission Management
Builds
Global regulatory submissions (INDs, CSRs, DSURs) for biopharma therapies
Domain
Biopharmaceuticals / Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Global submission management, regulatory project management, resource planning, subject matter expertise in regulatory submissions, knowledge of health authority requirements, document preparation, process improvement, cross-functional collaboration, team coaching
Preferred skills
Biopharma industry experience, managing submissions across multiple drug development stages, knowledge of specific therapeutic areas, analytical thinking, attention to detail, project management proficiency
Technologies
Smartsheet, SharePoint, Microsoft Office suite
Responsibilities
Manage a wide variety of global submissions including clinical study reports and original INDs; plan and oversee assigned submissions with global and regional content plans; act as subject matter expert for regulatory submission core capabilities; participate in development of submission standards and templates; coach and train less experienced colleagues; serve as lead for small to medium regulatory submissions
Seniority
Manager, hands-on IC with team leadership responsibilities
