• Coordinate efforts associated with the preparation of regulatory documents or submissions.
• Analyze product complaints and make recommendations regarding their reportability.
• Ensuring all data is compliance with regulations set by Egyptian Drug Administration (EDA) and other authorities if the product is for exportation.
• Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
• Provide strategic advice to senior management throughout the development of a new product.
• Project manage teams of colleagues involved with the development of new products.
• Ensure that a company’s products comply with the regulations of the regions where they want to distribute them.
• Keep up to date with national and international legislation, guidelines and customer practices.
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