Job Description
● Implement and follow up on all technical and scientific affairs in the process of importing raw materials, production, and distribution. ● Obtain legal permission for importation and clearance of products. ● Control batch record of each batch of pharmaceutical products in order to include all product information and quality control results. ● Provide timely reports on destruction, recall, and counterfeit products. ● Assist the regulatory affairs manager in recall management. ● Assist the regulatory affairs manager in PMQC management. ● Monitor and follow up on complaints, and technical and quality defects of medicines. (referral and follow-up of complaints from the relevant company, Iran Food and Drug Administration, Pharmacovigilance manager if used, etc.). ● Assist the regulatory affairs manager in return management. ● Assist the regulatory affairs manager in destruction management. ● Ensure compliance with GMP principles in the production process. ● Ensure compliance with the conditions of storage and transportation of products from the manufacturer to the warehouse of the distributor. ● Monitor the storage conditions of retained samples and stability study of samples. ● Inform any variation, including packaging, box contents such as dosage form, batch number, expiration date, etc., which is not in accordance with the issued license and relevant regulation to the Iran Food and Drug Administration, technology transfer department, supply chain and sales, marketing and business development. ● Collaborate in issuing the release form of manufactured products. ● Participate in training courses which are held by the Iran Food and Drug Administration. ● Release the product after receiving the documents from the technology transfer department and performing a batch record review. ● Periodic audit of the manufacturing site. ● Cooperate with the marketing and business development department in order to review and comment on promotional materials (leaflets, pharmaceutical magazines, etc.). ● Manage samples sent to the laboratories of the Iran Food and Drug Administration. ● Present regular reports about carried-out activities to the regulatory affairs manager. ● Perform other given duties by the regulatory affairs manager.
Requirements
● Bachelor's or Master's degree in Chemical, Pharmaceutical, Medical, or Paramedical Sciences. ● At least 2 years of experience in similar positions. ● Familiar with GXP principles and technical documents e.g.; CTD, CPP, COA, Proforma, Invoice, GMP certificate, DIAF, etc. ● Familiar with regulations, rules, instructions, and policies of the Food and Drug Administration of Iran, the registration process and Iran Drug List, TTAC, IRC, and quotation and planning systems. ● Familiar with quality assurance and international regulation e.g.; FDA, EU, etc. ● Sense of human relations, capability to work in a team, Independence, and initiative. ● Task orientation, technical knowledge, hardworking, and integrity. ● Ability to undertake multiple tasks at the same time without losing focus. ● Self-motivated individual with effective organizational skills. ● Must be proactive, with the ability to meet and surpass project deadlines. ● Good knowledge of Microsoft Office, especially Outlook. ● Exceptional analytical reasoning skills to think about problems thoroughly and generate solutions. ● Communication and negotiation skills. ● Time and stress management skills. ● Good command of English. ● Reliable, trustworthy, and good-tempered.
Employment Type
- Full Time
Job Category
Seniority
Details
Employment type
- Full Time
Job Category
Seniority
