Browse Jobs
For Employers
Post JobLog inGet Started

Regulatory Affairs Manager

Vamer Pharma
New Cairo, Cairo
Posted 4 years ago
121Applicants for1 open position
  • 118Viewed
  • 15In Consideration
  • 70Not Selected
Search other opportunities

Job Details

Experience Needed:
Career Level:
Education Level:
Salary:
Job Categories:

Skills And Tools:

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

Featured Jobs

Similar Jobs

Search other opportunities
JobsAdministrationRegulatory Affairs Manager