• Preparation of registration documents for Pharmaceuticals, Hygienic Products, Food Supplements & Natural Medicines
• Compile country specific re-registration and variation files
• Follow-ups with the Iranian Ministry of Health on files review and ensure timely submission of additional documentation requested
Requirements
• Good knowledge about writing SOP and other related documents
• Familiar with international GMP guidelines specially PIC/S
• Familiar with Pharmacopeia especially USP
• Proven track record in regulatory affairs with strong connection to health care authorities.
• Preferably reputable with credibility in font of MOH
• Ability to work in a team environment, handle multiple tasks
• Being able to handle the stress of tight deadlines and a fast paced work environment
• A strong knowledge of MS office programs.
• Strong communication skills
• Excellent documentation skills
• Flexibility and adaptability
• Excellent command of English