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Senior Regulatory Operations Manager
Job Summary
A company is looking for a Senior Manager, Regulatory Operations.
Key Responsibilities
- Ensure correct usage of clinical templates and submission readiness of regulatory documents
- Coordinate document publishing activities and support Medical Writing and Safety/Pharmacovigilance
- Serve as the liaison between functions and Regulatory Operations Submissions Vendors
Required Qualifications
- BA/BS degree is desirable
- 4+ years in pharmaceutical industry regulatory systems/operations
- Experience with regulatory information and document management systems
- Knowledge of eCTD submissions and clinical regulatory document lifecycle
- Experience in developing processes and delivering training for regulatory systems
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COMPLETE JOB DESCRIPTION
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