• Collect and coordinate information and prepare regulatory documentation and Product Dossier (CTD & ACTD) for submission to regulatory agencies in different countries especially Africa, South Asia and Middle East.• Maintain regulatory files/database and chronologies in good order.• Establish and maintain system for tracking changes in documents submitted to agencies or partners.• Actively participate in evaluation of regulatory compliance of document / product / process /test… Show more • Collect and coordinate information and prepare regulatory documentation and Product Dossier (CTD & ACTD) for submission to regulatory agencies in different countries especially Africa, South Asia and Middle East.• Maintain regulatory files/database and chronologies in good order.• Establish and maintain system for tracking changes in documents submitted to agencies or partners.• Actively participate in evaluation of regulatory compliance of document / product / process /test methods changes. • Participate in regulatory issues and dissemination regulatory information to Production, QA, QC and R&D departments and senior management as required.• Maintain communication and business relation with assigned market counterpart for smooth business operation.• To prepare regulatory documents like COPP, Form 10 A and FSC. Show less

• QA inspection during dispensing of raw materials. • In-process inspection and line clearance in Production area.• Sampling of intermediate & finished product.• Document, BPR / BMR compilation, checking, archiving, retrieving when necessary and dispose of expired documents.

• Sampling of raw materials (both active & excipients) and perform test accordingly.• Sampling of intermediate and finished product.• In-process inspections during production.