Regulatory Affairs Manager

Job Description

• Supervise the regulatory team.
• Create and manage effective communication and close collaboration with MOH
• Keep up-to-date with the latest news in MOH, syndicates, and the pharmaceutical industry.
• Prepare and complete regulatory documentation for submission to MoH.
• Support the maintenance of regulatory files in compliance with regulations and standards applicable to company products.
• Manage and conduct pharmacovigilance activities.
• Develop and execute strategies related to organizational goals aligned with MOH to meet objectives.
• Manage and conduct GDP activities including quality risk management of GDP deviations for all imported products.
• Monitor and control all necessary documents and release of the batches of imported pharmaceutical products.
• Track variations and changes in production lines for submission to regulatory authorities.

Requirements:

• PharmD (Pharmacist).
• At least 2 years of managerial experience in related fields.
• Familiarity with the principles of GXP (GLP, GDP, GSP, GMP, etc.) based on the international GMP guidelines.
• Strong communication skills.
• Able to work under pressure and tight deadlines.
• Fluent in English.
• Capable of traveling and site visits.
• Familiar with Iran FDO regulation and TTAC system.