Senior Regulatory Submission Specialist

Job Summary

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

Key Responsibilities:

• Track Clinical Trial Application (CTA) submission deliverables and maintain updates across platforms
• Manage regulatory agency communications and document transfers between internal teams and CROs
• Collaborate with cross-functional teams to ensure efficient documentation processes

Required Qualifications:

• Familiarity with regulatory agency regulations and guidelines (e.g., FDA, EMA, ICH, eCTD)
• Experience managing global Clinical Trial Applications (e.g., IMPD preferred)
• Understanding of pharmaceutical drug and device development processes
• Knowledge of regulatory affairs, operations, or information management
• Practical experience with RIM technologies is a plus