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Job Description
- Prepare the regulatory documents needed to attain the approval of regulatory agencies needed for the registration of pharmaceutical products in addition to acting as the liaison between HIKMA and the regulatory authorities.
- Preparing clear arguments, explanations and presentations for regulatory organizations to resolve any issues related to new product licenses, renewals and variations
- Reviewing company related practices, handling regulatory inspections and providing advice on required modifications to Hikma systems according to governmental policies and regulations
- Writing clear comprehensive product labels and leaflets in compliance with regulations and specifications.
- Performing other duties related to the job as assigned by the direct supervisor
Job Requirements
- BSc. of Pharmacy
