Regulatory Affairs Specialist

Job Description

• Gathering, evaluating, organizing, managing and collating all Export regulatory related information on
• registration instructions and regulations in a variety of formats.
• Prepare the registration application files in accordance to the local regulations (AW, claims, and technical files) to present to EDA or in Foreign countries
• Follow up submission and any supporting documents along with registration lead time.
• Ensure that Products Claims are complied with local MOH regulations and legal requirements.
• Follows up with the application deadline and gathers the required documentation from Country of origin.
• Maintain knowledge on all rules and regulations of import processes and ensure efficient transmission of all import & local goods.
• Dealing with existing products and expanding company portfolio with new products including pharmaceuticals.
• Building up & submitting files to competent authority
• Prepare analytical files to be submitted to different authorized labs
• 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.
• Ensure all registration activities are in compliance with the company and National laws & regulations.
• 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

• Pharmacy/science/vet medicine graduate
• From 2 to 5 years of experience
• CTD Experience is preferable
• Knowledge of pharmaceutical legislation, relevant guidelines, procedures and requirements
• Fluent in oral and written Arabic and English
• Time management skills
• Team player