Regulatory Manager
Cobel Group
Manage the registration, renewal, and update processes for both locally manufactured and imported pharmaceutical productsOversee compliance of products and company activities with the requirements of the Iranian FDA, GMP, and other relevant regulatory standardsMaintain ongoing communication with relevant authorities to follow up on registration files and respond to regulatory feedbackReview and approve technical documentation provided by foreign suppliersSupervise training programs for staff on regulatory requirements and quality standardsParticipate 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.
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