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Regulatory Affairs Section Head

Premier Services and Recruitment
New Cairo, Cairo
Posted 4 years ago
99Applicants for1 open position
  • 9Viewed
  • 0In Consideration
  • 0Not Selected
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Job Details

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Job Description

  • Maintain products’ lifecycle and licenses and ensure timely re-registration for the company's products
  • Preparation, submission and follow-up on the stability files, all through the Central Administration of Pharmaceutical Affairs till receiving final MA.
  • Preparation, submission and follow-up on analytical testing files, through NODCAR till receiving final MA.
  • Follow up with GRA/ GRPD/Local sites regarding variations and liaise the submission and follow up with MOH.
  • Maintain an up to date regulatory archive for Egypt regulations (registrations, re-registrations, variation procedures, labelling, requirement, application forms, fees and guidelines)
  • Ensure all dispatched CMC variations and related PAC are submitted to plan and ensure the regulatory data comply with the applied in the GMS, matched with both the comapny's standards and MOH requirements.
  • Ensure the fulfillment of PAC until getting the final approval from the MOH to maintain product supply.
  • Submission of yearly bulk plan of Cairo site and Labelling files of selected products.
  • Maintain a good tracking for submission and approval through preparation of monthly reports reflecting actual activities and dates.
  • Set accurate timelines for licenses expiration, re-registration process steps, variations submission and approvals, and related PAC

Job Requirements

  • Technical / Admin background knowledge.( Registration/re-registration /all type variations )either in CAPA/NODCAR
  • Relationship management building skills, with the ability to interact and manage multiple and varied business contacts, both internal and external, often with different requirements and goals .
  • Fair knowledge of Regulatory processes within both manufacturing sites & MOH   in addition to regulations background.
  • Excellent knowledge for the content of Registration files (Local/under licence ) & CTD 
  • Strong planning ability and able to work on own initiative with a strong problem-solving skills.
  • Excellent written and verbal communications skills in English in addition to excel and word using.

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