Responsible for preparation of Registration dossiers of all new products and Re-registered products
Responsible for preparation and submission of Analytical dossiers to NODCAR (National Organization for Drug Control and Research)
Follow up all steps of registration in MOH (Ministry of Health) including Stability Study, Bioequivalence Study, Inserts, Packs and Analysis
Follow up any change needed in any product such as change in pack, formula or name.
Ensure all registration activities are in compliance the company and National laws & regulations.
Ensures confidentiality in respect of registration files contents
Carefully review compiled files to ensure that content, quality, accuracy and format of submission Comply with applicable regulations of the market
Develop and maintain registration track record for the market
Communicate with external suppliers to request certificates complete the required documents for registration.
Responsible for providing samples for the ministry of health laboratories and receiving the results of the analysis.
Responsible for following up the customs clearance.
Tagged as: DOS