Job Description
Preparing, completing and reviewing registration files for pharmaceutical products in CTD format.
Preparing and following up on registration, renewal, amendment and change files for products.
Reviewing and updating documentation in accordance with the latest regulations and directives of the Food and Drug Administration and the Drug Administration.
Following up on obtaining and renewing registration licenses, production licenses, IRCs and other related licenses.
Preparing and sending correspondence and documents required to the Food and Drug Administration and following up on responses.
Reviewing and responding to deficiencies and errors in registration files and coordinating with relevant units to complete the documentation.
Cooperating with production, quality control, quality assurance, research and development and commercial units to prepare regulatory documentation.
Reviewing changes in formulations, raw materials, production process, packaging, test methods and suppliers in terms of regulatory requirements and the need to register changes.
Preparing and following up on Variation / Change Control files and other changes after registration.
Controlling and maintaining records of licenses, permits, correspondence and regulatory documents.
Continuously monitoring laws, guidelines and circulars related to pharmaceutical products and informing relevant units of changes.
Participating in Food and Drug Administration inspections and preparing required documents.
Reviewing and controlling information included on packaging, labels, brochures and product information from the perspective of regulatory requirements. Following up on processes related to name approval, price, advertising licenses and other licenses related to the product if needed.
Preparing periodic reports on the status of files, licenses, extensions and actions being followed up.
High accuracy, process-oriented and result-oriented
