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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