Snr Regulatory Affairs
Current Collation and compilation of common technical document for Dossier Preparation Follow up of Internal customers and External customer to make sure scheduled work plan for the year is achieved timely and as planned. Ensuring timely and routine inspection of manufacturing facility and ware houses. Ensuring timely registration of new and existing products to meet agreed timing targets. Following up of products undergoing registration at each stage with NAFDAC Ensuring that prompt response is given to the indications/ directives received from the regulatory body concerned. Ensure timely submissions and collection of approval according to the regulatory work plan and as requested. Ensuring product licensed are renewed, permits are processed for active pharmaceutical ingredient and raw material to enable continuity of production and sales. Ensuring processing of permits to import and permits to clear, for controlled drug products and substances. Ensuring timely endorsement of products when imported and timely removal of hold label when such products are placed on hold. Ensuring timely registration of the premises, pharmacists with the appropriate regulatory authorities. (NAFDAC, PCN) Ensuring that NAFDAC approval is obtained for adverts of food and drug products. Support and ensure regulatory department comply to the company Quality management system. Develop a risk register that limits risk to its minimum for the department and company.
