مدیر امور رگولاتوری

Job Description

Regulatory Affairs Manager
Daryan Salamat Pharma Group (Est. 2007) – Tehran

Job Summary:
Daryan Salamat Pharma Group is looking for an experienced Regulatory Affairs Manager to handle regulatory submissions, product registration, and product release processes. The ideal candidate must be fully familiar with IFDA procedures and capable of ensuring smooth regulatory follow-up through strong understanding of internal systems and established professional workflow within the Food and Drug Organization.

Responsibilities:
• Prepare and submit CTD/eCTD dossiers for pharmaceutical products and raw materials
• Manage all communications and follow-ups with IFDA
• Release finished products according to national regulations
• Handle product registration, renewals, variations, and labeling updates
• Ensure compliance with pharmacovigilance requirements
• Maintain regulatory data in TTAC and Chargoon systems
• Coordinate with QA, QC, Production, and R&D for documentation and approvals
• Monitor regulatory updates and ensure compliance
• Prepare and control regulatory SOPs
• Conduct in-person regulatory follow-ups when required

Requirements:
• PharmD (Doctor of Pharmacy) – required
• Minimum 4–5 years of experience in pharmaceutical regulatory affairs
• Strong familiarity with IFDA processes and efficient regulatory follow-up capability
• Experience in product release
• Excellent English proficiency
• Strong documentation and communication skills
• Proficient in MS Office