Executive Coordinator /Regulatory Affairs Incharge
Behzad Medical Establishment
Total years of experience :13 years, 8 Months
• As Executive Coordinator & Regulatory in-charge Responsible for All kind of Drug Regulatory Operations & Technical negotiations with Bahrain National Health Regulatory Authority.
• In collaboration with International RA Strategists, provide regulatory strategies to responsible functional groups and regulatory management, Working in association with Regulatory Teams of Leo Pharma, OM Pharma, Tabuk Pharma KSA, SPIMACO Pharma KSA, Boehringer Ingelheim, PSI Pharmaceutical KSA, GSK, Sanofi etc.
• Responsible for reviewing and submission of CTD & eCTD New Drug application (NDA), Renewal of Product license, , Variations submissions, Classification of products, Health Product registration, Cosmetic registration.
• Responsible for Medical Devices & Combined Medical Devices Registration, Renewal & variation.
• Responsible for Healthcare facilities (Pharmacy & warehouse) Registration & Renewal.
• Act as a point of contact for the assigned projects and as interface with key corporate functional areas.
• Prepare and maintain project plans and timelines of approvals and planned submissions.
• Responsible for premarket approval of drugs from NHRA.
• Interact with Principal Companies, service providers and regulatory agencies to resolve related review questions.
• Develop relevant regulatory department local operating procedures (CMLR etc.).
• Responsible to take care of Behzad Group 6 Retail outlets(pharmacies) regarding administrative point of view.
• Responsible to report NHRA team about the rectification done as Per NHRA requirements in Pharmacies.
• Responsible for recall of any products from pharmacy branches and Pricing issues with other Distributors.
• Act as a point of contact for PV system compliance.
• To Keep record of All AE reports, Pharmacovigilance SOP’s as per SDEA with MAH.
• To ensure compliance of Good Pharmacovigilance Practices in BME.
• To provide training to relevant staff regarding Pharmacovigilance in absence of NRPP.
• Responsible for Pharmacovigilance Audits.
• Act as a point of contact for DUR system (Drug Utilization Review) with SCH (Supreme Council of Health.)
Trainings.
Received on job Training for Pharmacovigilance compliance system by GE Healthcare, GSK and DUR (Drug
utilization Review) Training by Supreme Council of Health Bahrain.
• Arranging appointments with doctors, pharmacists and hospital medical teams, which may include pre- arranged appointments or regular 'cold' calling;
• Making presentations to doctors, practice staff and nurses in GP surgeries, hospital doctors and pharmacists in the retail sector.
• Building and maintaining positive working relationships with medical staff and supporting administrative staff.
• Keeping up to date with the latest clinical data supplied by the company, and interpreting, presenting and discussing this data with health professionals during presentations;
• Monitoring competitor activity and competitors' products;
• Arrange activity and events to increase the noise level of my products.
• Develop High value relationship with Key Customer.
Trainings:
• Received on job multiple products training related with cardio metabolic group and also received in depth knowledge about physiology, pharmacology and pathology.
• Received multiple training in basic selling skills and management skills from HighNoon Laboratories.
• Training on communication and time managements skills from HighNoon laboratories.
Worked in cardiometabolic group as medical representative.
Registered Pharmacist- Punjab Pakistan