CTD and Documentation Section Head

FPi-Future Pharmaceutical Industries is a company seeking qualified professionals to contribute to its operations. The organization is currently looking for a CTD and Documentation Section Head, indicating an interest in regulatory compliance and document management within the pharmaceutical sector. While specific details about the company’s industry, size, or locations are not provided, the job title suggests involvement in drug development processes, particularly those requiring adherence to regulatory standards such as ICH guidelines. The role implies a need for expertise in compiling and maintaining technical documentation, which is critical in pharmaceutical research and commercialization. As a result, FPi-Future Pharmaceutical Industries appears to be engaged in activities related to pharmaceutical product development, though further information would be required to confirm the exact nature of its operations.

Future Pharmaceutical Industries (FPI) is looking for a qualified CTD & Documentation Section Head to join our Product Development team. Key Responsibilities: Support strategic planning and execution of CTD activities for new development, variations, and product lifecycle management. Ensure compliance of all CTD submissions with regulatory standards. Review final CTD dossiers, variations, renewals, and technical files. Manage CTD team performance, training, and capability development. Put on the monthly and weekly plan of work and ensure its implementation accurately. Review SOPs, specifications, and test methods of the document center. Report monthly productivity to the Methodology Manager. Supervise material qualification, DMF evaluation, and supplier documentation reviews. Coordinate with Formulation, QC, QA, RA, Supply Chain, and Planning to ensure dossier consistency. Ensure CTD documents comply with ICH, EDA, and export country requirements. Monitor project timelines, risks, and deliverables related to CTD activities. Advise and consult with PD staff concerning reviews, regulations, and operational policies. CTD & documentation deputy manager delegate in his absence. Requirements: Bachelor’s degree in Pharmacy or Science. Minimum 7 years of relevant experience in CTD and documentation activities. Strong knowledge of CTD requirements and ICH guidelines; RA knowledge is preferred. Very good command of English and Microsoft Office. Strong organizational, leadership, and teamwork skills. Show more

The CTD and Documentation Section Head oversees the creation and maintenance of regulatory documentation for pharmaceutical products. This role ensures compliance with industry standards and supports the development of high-quality documentation processes.