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eCTD Submission Manager
A company is looking for an eCTD Submission Manager II to manage electronic submissions for regulatory compliance. Key Responsibilities Manage eCTD submissions for global development and lifecycle management Oversee outsourced publishing deliverables to ensure operational success Act as the primary contact for regulatory functions and ensure compliance with submission standards Required Qualifications Bachelor's degree required 3-5 years of experience in regulatory operations and submissions Expertise in regulatory systems (e.g., InSight, Veeva, Docubridge, CARA) Experience in eCTD submission management UAT testing and IT/system implementation experience preferred
A company is looking for an eCTD Submission Manager II to manage electronic submissions for regulatory compliance.
Key Responsibilities
Manage eCTD submissions for global development and lifecycle management
Oversee outsourced publishing deliverables to ensure operational success
Act as the primary contact for regulatory functions and ensure compliance with submission standards
Required Qualifications
Bachelor's degree required
3-5 years of experience in regulatory operations and submissions
Expertise in regulatory systems (e.g., InSight, Veeva, Docubridge, CARA)
Experience in eCTD submission management
UAT testing and IT/system implementation experience preferred