• Follow-ups with MOH and IFDA on files review and ensures timely submission of additional documentation requested
• Review documents as CTD, PMFs, to fulfill MOH requirement for registration
• Familiar with TTAC portal of MOH and material registration.
• Develop professional relationships with MOH staff and proactively monitor relevant governmental bodies to identify changes in legislation/regulations
• Supervision of quality processes
• Familiar and provision of SOPs
• Review product printing materials, labeling, specification sheets with applicable regulations and policies.
• Supervising all product quality activities according to internal and external standards such as GMP and …
Requirements
• Pharm.D. Pharmacist Female/male
• Having minimum 5 years of experience in pharmaceutical industries
• Familiar with the field of Probiotics
• Interest and experienced in QA and regulatory affairs
• Strong communication skills and high team work value
• Good command of English and computer skills
• Location: Tehran office and Goldasht Karaj plant