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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 change in pack, formula or name.
- Ensure all registration activities are in compliance 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 registration track record for the market
- Communicate with external suppliers to request certificates complete the required documents for registration.
- Responsible for providing samples for the ministry of health laboratories and receiving the results of the analysis.
- Responsible for following up the customs clearance.
Benefits.
- Transportation allowance.
- Mobile allowance.
Job Requirements
- Experience: 1 - 3 in regulatory affair is preferable
- Bachelor of scientific colleges (pharmacy -veterinary - sciences)
- Proficient level of written and spoken English language
- Knowledge of regional laws and regulations relating to pharmaceutical product registration.
