Regulatory Affairs Specialist

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 permeations for any Shipment from CAPA.
• Responsible for following the Analysis Certificates from NODCAR .

Education and Experience

• Medical background degree or equivalent professional qualification
• At least 2 years 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
• stress tolerance
• collaboration
• send CV to: jobs@vamerpharma.com with job title in subject line.