Director, Global Submission Management
Core
Strategic oversight and execution of a global portfolio of regulatory submissions across development and lifecycle programs to enable product registrations.
Role type
Director, Global Submission Management
Builds
Global product registrations and regulatory compliance
Domain
Biotechnology / Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | client delivery | infrastructure | physical/clinical work
Required skills
Global regulatory submission requirements knowledge, submission and project management tools, multi-program portfolio management, cross-functional coordination, risk management, people management, MS Project, Smartsheet, Veeva RIM
Preferred skills
AI-driven tools adoption, emerging technology awareness, competitive intelligence analysis
Technologies
MS Project, Smartsheet, Veeva RIM
Responsibilities
Develop and maintain submission plans and timelines, ensure consistent application of submission standards, coordinate cross-functional activities for submission completeness, identify and resolve operational risks, oversee preparation of status updates and reporting, lead and coach submission management staff
Seniority
Director, strategic oversight and team leadership
