Regulatory Expert

Job Description

This position will assist in develop of new products. The applicant must have a spirit of hard work and patience to achieve the goals, she/ he also needs to be motivated to solve a technical challenge.
• 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, provide reports on a regular basis to QA manager.
• Familiar with TTAC website, registration of supplements and APIs, 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.
• Support maintenance of regulatory files in compliance with regulations and standards applicable to company products.
• Capable of traveling and site visits
• Carrying out all the procedures for obtaining the manufacturing license of new drugs and taking timely action to renew the manufacturing license of current products according to GMP regulations.
• Receiving reports of periodic inspections of the MOH in order to correct and eliminate deficiencies and follow up to eliminate deficiencies and report corrective actions
• Planning for continuous modification and improvement and carrying out internal inspection
• 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, and ….