Senior Regulatory Affairs Manager

ALFA MEDICAL - Heliopolis, Cairo

Applicants for
1 open position
Experience Needed:
More than 5 years
Career Level:
Experienced (Non-Manager)
Job Type:
Full Time
8,000 to 12,000 EGP per month, Social Insurance, Profit share, other allowances
1 open position
About the Job
  • Planning and Monitoring of the Regulatory Context
  • Registration of new products
  • Maintain and update labeling & variations
  • Carry out the planned RA Activities e.g. Pack Size Additions, Artwork Approvals
  • Preparation & submission of BE files with follow up with the third party center and Health Authority
  • Assure compliance with IA files
  • Price Preparation, submission & follow up of files and documents in the required Timelines.
  • Following and complying with all the defined internal policies and procedures of working.
  • Strictly following all the Authority Regulations, decisions & decrees.
Job Requirements
  • Bachelor of pharmacy, sciences or veterinary
  • 5 Years at least of experience in a similar position
  • Residence near Heliopolis
  • Computer skills, Negotiation & Communication skills.
  • Good Command of English Language
  • Organization skills and high accuracy in documentation
  • High sense of urgency
  • Knowledge of new decrees & Guidelines
  • Time management
  • Awareness & adherence to company internal SOPS & compliance standards promptness in deliverable & in response to authorities’ requirements.
  • Understand the link between own priorities & the organization.
  • CTD & E-CTD
About this Company

Professional organizers for Medical Conferences and International Trade Fairs and Exhibitions within Africa and Middle East.

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