Nouha Drine

Regulatory Affairs Publisher @Pharmascience

Regulatory Documentation Management:• Ensure regulatory documents are properly formatted for electronic submissions and internal standards.• Transfer new documents into the Document Management System (DMS) and maintain consistent attributes.• Manage the lifecycle of documents within the DMS and classify key regulatory documents according to internal requirements.Regulatory Submission Compilation:• Build and transfer regulatory submissions using the Submission Management System (SMS).• Ensure the structure of submissions meets internal, regional, and ICH specifications.• Maintain consistency of submission attributes according to regional and ICH specifications.Publication, Validation, and Submission:• Publish and deliver regulatory submissions in the required format to internal clients.• Perform electronic validation of published files and ensure submissions adhere to validation criteria.• Ensure timely delivery of required deliverables to internal clients (other Regulatory Affairs teams).