● 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 regulations 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.