Regulatory Affairs Manager

Job Description

• Supervise the regulatory team.
• Create and manage effective communication and close collaboration with MOH.
• Keep up-to-date with the latest news in MOH, syndicates, and the pharmaceutical industry.
• Prepare and complete regulatory documentation.
• Support the commanded strategies to increase the time and accuracy of regulatory compliance.
• Monitor and control all necessary manufacturing, packaging, associated documents, test and release of the produced batch of the pharmaceutical product, and compliance with the requirements of Good Manufacturing Practice.
• Establish and maintain a system for tracking document changes submitted to regulatory authorities or partners.
• Support 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:

• Capable of traveling and site visits.
• Submissions to the MOH, product registration, consumer information, and all regulatory activity teams working on preparing the required documentation for submitting the pharmaceutical dossier to the Ministry of Health including CTDs, SOPs, and reports.
• Pharmacist (PharmD).
• At least 5 years of experience as a responsible pharmacist.
• Gender preference: Male/Female.
• Fluent in English.