Responsible Pharmacist

Job Description

• Food supplement, special food for medical purposes & Drug registration applications in a timely manner
• Supervising regulatory team
• Create and manage effective communication and close collaboration with MOH
• Keeping up-to-date with the latest news in MOH, syndicates and pharmaceutical industry.
• Preparing and completing Regulatory documentation
• Familiar with IRC, TTAC website, registration of supplements and APIs, Working standard , medicines & getting IRC in MOH.
• Support the commanded strategies to increase the time and accuracy of regulatory compliance.
• Establish and maintain a system for tracking changes in documents submitted to regulatory authorities or partners.
• Support in collecting and coordinate information and prepare regulatory documentation for submission to regulatory affairs.(medicines and special food for medical purposes)
• Support maintenance of regulatory files in compliance with regulations and standards applicable to company products.
• Capable of traveling and site visits
• Submissions to the MOH, product registration, consumer information and all regulatory Activiti Team working in preparing the required documentation for submitting the pharmaceutical dossier into the ministry of health includes CTDs, SOPs, Reports
• Managing and conducting pharmacovigilance activities
• Price request submission to MOH according to MOH rules for price correction
• Maintenance of history of pricing changes
• Filling Rolling Forecast for medicines and special food for medical purposes
• Preparation of required document related to “ consumption correction “and submission to MOH
• Getting Quota and price approval for first shipment of new product
• Develops and executes strategies related to achieve organizational goals aligned with MOH meet objectives
• Conducting Quality Risk management of GDP deviations in Iran
• Managing and conducting GDP activities including the correct distribution plans for all imported product according to the negotiation previously done with MOH distribution plans
• Monitoring and report MOH shortage list on a monthly basis
• Conducting market access activities including:
1. Critically appraise clinical evidence to both payers and MOH Insurance committee
2. Identify competitors, and pricing in the therapeutic area
3. Understanding products’ value propositions and applying to reimbursement potential
4. Review of all market access submission materials, including supporting Budget Impact Assessments (BIA), Pharmaco-economic studies (PE), Clinical Summaries and other materials