Regulatory Affairs Specialist

Job Description

• Responsible for preparation of Registration dossiers of all new products and Re-registered products.
• Responsible for preparation and submission of Analytical dossiers to NODCAR ( National Organization for Drug Control and Research )
• Follow up all steps of registration in MOH (Ministry of Health) including Stability Study, Bioequivalence Study, Inserts, Packs and Analysis.
• Follow up any change needed in any product such as a change in pack, formula or name.
• Establish and maintain a good relationship with the internal and external stakeholders.
• Coordinate with the R&D, Q.C, Production, Marketing team members regarding the different registration issues.
• Ensure all registration activities are in compliance with the company and National laws & regulations.
• Ensures confidentiality in respect of registration files contents.
• Carefully review compiled files to ensure that content, quality, accuracy and format of submission Comply with applicable regulations of the market.
• Develop and maintain a registration track record for the market

Job Requirements

• Experience in the dietary supplement and human drugs.