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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
