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Senior Regulatory Submission Specialist

7/9/2025

No location specified

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

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