Regulatory Submission Specialist

Job Summary

A company is looking for a Regulatory Submission Project Management Specialist.

Key Responsibilities

• Schedule and manage routine regulatory submissions, including IND safety reports and clinical site documentation updates
• Support monitoring and tracking of submission processes for clinical site documentation
• Coordinate publications for submissions and manage overall completeness of scheduled submissions

Required Qualifications

• Bachelor's Degree
• 0-2 years of industry and/or relevant experience
• Strong knowledge of applicable Regulatory Agency regulations and guidelines (e.g., FDA, EMA, ICH)
• Experience with submission processes and systems
• Knowledge of eCTD and document management systems, including VEEVA Vault and MS Office applications