● Support all regulatory affairs activities in order to achieve and maintain registration in compliance with all national and regional regulatory and legal obligations.
● Effectively manage priorities in order to implement corrective and preventive actions.
● Appropriately apply principles of continuous improvement.
● Annual product reviews and review of stability reports for compliance with food and drug regulations.
● Monitor QA aspects of warehousing practices in compliance with warehouse procedure manuals.
● Timely approval of incoming batches, batch inspection, and release according to SOPs.
● Liaise with customers and regulatory authorities regarding quality matters, including hosting inspections and responding to observations.
Requirements
● Preferably a resident of Karaj or West of Tehran.
● Pharmacist (Pharma D) with valid Pharma license or other related fields of study.
● 3 plus years relevant experience in the regulated pharmaceutical industry, specifically including Quality Assurance, Quality Control, and/or Drug Regulatory Affairs.
● Experience with GMP, ISO 9001.2015, ISO 13485 inspections, and third-party audits.
● Understanding of pharmaceutical policies and rules.
● Solid computer skills, using MS Office.
● Fluency in English especially in writing.