Job Details
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Job Description
General Purpose:
To advise on and coordinate the approval and registration of company products. Plays as a crucial link between their company, its products and regulatory authorities
Main Job Tasks and Responsibilities:
Manage regulatory affairs team and follow up the below with them :
- Collecting and coordinate information and prepare regulatory documentation for submission to regulatory agencies or to commercial partners
- ِِِِAdvise on the submission strategy Timely compile materials for license renewals, updates and registrations Maintain regulatory files/database and chronologies in good order.
- Establishing and maintaining system for tracking changes in documents submitted to agencies or partners Responsible for all steps of Research issues
- preparation of Registration files for any new product.
- creating Designs for New products.
- Registration of Drugs, Cosmetics, Food Supplements & Medical devices in CAPA.
- Registration of Special Nutrition in NIN.
- following steps of formulations and stability study of any New products.Responsible for execution of Damaged and Expired products in Vacsera.
- Getting Release permeation for any Shipment from CAPA Responsible for following the Analysis Certificates from NODCAR
Job Requirements
Education and Experience:
- Medical background degree or equivalent professional qualification
- At least 5 year relevant experience within the regulatory affairs discipline
- Knowledge of Egyptian and international medical device regulatory requirements
- Relevant product and industry knowledge
Key Competencies:
- Excellent written and verbal communication skills organization and planning
- Problem analysis and problem-solving
- Persuasiveness, adaptability, judgment, decision-making tolerance & collaboration