Regulatory Expert

Rougine Pharmed Tehran

Posted 2 years ago

Job Description

● Register the products at the commerce department. ● Follow up on the imported products for the commerce portals. ● Prepare and deliver the required documents for releasing the goods from the TTAC. ● Prepare reports for the finance department about locally manufactured products. ● Upload XML files for the produced products and register them on the MOH portal. ● Prepare the required letters for the distributing companies. ● Help with preparing documents for regulatory issues. ● Follow up the registration process at the MOH. ● Prepare and complete regulatory documentation, and provide reports on a regular basis to the QA manager. ● Register supplements and APIs, and medicines, and get IRC in the MOH TTAC portal. ● 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 coordinating information and preparing regulatory documentation for submission to regulatory affairs. ● Support maintenance of regulatory files in compliance with regulation and standards applicable to company products.

Requirements

● Bachelor's degree. ● At least 2 years of experience in the regulatory field and pharmaceutical industry. ● Familiar with regulatory affairs and MOH procedures. ● Strong communication skills. ● High teamwork value. ● Proficient in English. ● Attention to detail. ● Decision-making and problem-solving skills. ● Time management skills. ● Proficient in Microsoft Office.

Employment Type

  • Full Time

Details

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