Senior Regulatory Operations Manager
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
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
