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Senior Regulatory Affairs Specialist

New Nozha, Cairo
Posted 3 years ago
79Applicants for1 open position
  • 58Viewed
  • 0In Consideration
  • 0Not Selected
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Job Details

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Job Description

Advance Pipeline/Marketed Product Support: Submissions, Renewals & Approvals:

  • Ensure that all regulatory submissions for Egypt (New marketing authorization applications, renewals, variations, notifications) are prepared and filed in timely manner for company products.
  • Follow up all steps for Authorization/approval of these submissions.
  • Gain Regulatory Authority approval for marketing authorizations for new products (Early access for innovative products).
  • Maintain all existing product marketing authorizations and gain Regulatory authority approval of variations to these authorizations as required.
  • Manage any further information requests from local Regulatory authority in a timely manner, submission of any subsequent responses/product documentation updates to local Regulatory authority.
  • Review product information in accordance with legal and regulatory requirements; ensure that all prescribing information is accurate, update and approved by both company and relevant Regulatory authority in accordance with company policies and local regulations.
  • Registration of Veterinary Pharmaceutical  products
  • Registration of Food Supplements in NFSA

Job Requirements

  • Bachelor's degree in pharmaceutical, or veterinary medicine.
  • With minimum 5 years’ experience
  • Presentable, active listener, enthusiastic and communication skills
  • Have experience in registration of Veterinary Pharmaceutical  products
  • Have experience in registration of Food Supplements in NFSA

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