Job Description
● Prepare required information as requested by regulatory agencies (IFDA & MOH).
● Prepare or maintain technical files as necessary to obtain and sustain product approval.
● Work closely with TTAC website and follow up all affairs of regulatory department.
● Coordinate recall or market withdrawal activities as necessary.
● Review adverse drug reactions and the related reports in accordance with regulatory agency guidelines.
● Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies.
● Implement all instructions issued by Iran FDA regarding the importing raw materials, Biological finished products, production and distribution of medicines.
● Participate in internal or external audits and doing the required follow-ups.
● Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.
