About the Job

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

• Collect 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.
• Establish and maintain system for tracking changes in documents submitted to agencies or partners
• Responsible for all steps of Research issues
• Responsible for preparation of Registration files for any new product.
• Responsible for creating Designs for New products.
• Responsible for Registration of Drugs, Cosmetics, Food Supplements & Medical devices in CAPA.
• Responsible for Registration of Special Nutrition in NIN.
• Responsible for following steps of formulations and stability study of any New products.
• Responsible for execution of Damaged and Expired products in Vacsera.
• Responsible for getting Release permeation for any Shipment from CAPA.Responsible for following the Analysis Certificates from NODCAR .

Job Roles: Medical Pharmaceutical

Job Requirements

Education and Experience

• Medical background degree or equivalent professional qualification
• At least 1 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

Send C.V: info@vamerpharma.com

jobs@vamerpharma.com