مدیر رگولاتوری

Job Description

• Manage the registration, renewal, and update processes for both locally manufactured and imported pharmaceutical products
• Oversee compliance of products and company activities with the requirements of the Iranian FDA, GMP, and other relevant regulatory standards
• Maintain ongoing communication with relevant authorities to follow up on registration files and respond to regulatory feedback
• Review and approve technical documentation provided by foreign suppliers
• Supervise training programs for staff on regulatory requirements and quality standards
• Participate in management meetings to present performance reports, identify challenges, and propose improvement solutions

Requirements:

• Doctor of Pharmacy (Pharm.D), or MD.
• At least 7 years of experience in regulatory affairs and quality assurance in pharmaceutical companies, especially in the field of imports.
• Comprehensive knowledge of Iranian FDA regulations, GMP, and international standards.
• Proficiency in English, particularly in technical writing and communication.
• Strong team management, interpersonal, and communication skills.
• Proven experience in working with foreign suppliers and regulatory authorities.