Regulatory Affairs Documentation Officer x3

No detailed description provided.

• Maintain and update regulatory document control systems in accordance with GDP and data integrity principles. • Format, compile and archive regulatory documents required for product registration, variations, and renewals. • Assist in the preparation of CTD modules by ensuring proper document alignment, pagination and referencing. • Track document revisions, approvals, and submission timelines to ensure regulatory readiness. • Support electronic and paper-based submissions to local and international regulatory authorities. • Coordinate the collection and verification of technical data from cross-functional departments for submission. • Prepare and maintain regulatory trackers, logs, and indexes to monitor document status and submission history. • Ensure document compliance with applicable regulatory guidelines (e.g., NDA Uganda, WHO PQ, ICH). • Facilitate internal audits and regulatory inspections by ensuring timely document retrieval and version control. • Provide administrative support to the Regulatory Affairs team in document-related matters. • Minimum of 2–3 years’ experience in regulatory affairs or quality documentation in a pharmaceutical manufacturing setting. • Familiarity with CTD structure and documentation requirements for regulatory submissions. • Strong organizational and document control skills with attention to detail. • Knowledge of GMP, GDP, and data integrity (ALCOA+) principles. • Proficiency in Microsoft Office and document management systems (e.g., SharePoint, TrackWise).