Zeta Career - Feed https://career.zetapharma.net Zeta Career Thu, 12 Nov 2026 10:41:13 +0000 hourly 1 https://wordpress.org/?v=7.1.4 <![CDATA[Regulatory Affairs Senior Specialist]]> Mon, 21 Sep 2026 07:02:17 +0000 Sun, 21 Sep 2036 10:03:27 +0000 Wed, 21 Oct 2026 00:00:00 +0000
  • Complete renewal & exist products’ registration process at MOH.
  • Provides direct assistance with the registration of new and existing products in markets supplied by the plant.
  • Prepares and submit files and reports to related regulatory authority.
  • Coordinate & follow all steps of registration in EDA (Egyptian Drug Authority) including Stability Study, Bioequivalence Study, Inserts, Packs and NODCAR files till approval.
  • Follows up batches and raw material submitted samples for analysis till receiving conformity.
  • Implement and follow up any variations needed in any product such as change in pack, formula …….etc.
  • Submit and Follow up and any supporting documents along with registration lead time.
  • Track the application deadline updates and gathers the required documentation from related parties.
  • Coordinate & collaborate with the R&D, Q.C, Production, Marketing team members.
  • Communicate regulatory information to multiple departments.
  • Maintains current knowledge of updated regulatory guidelines.
  • Establish and maintain professional relationships with the internal and external stakeholders.
  • Implement and maintain registration tracking system for publishing document submissions either in hardcopy or electronic formats.
  • Resolve or follow up complaints to ensure effective and timely resolution of all complaint investigations.
  • Notifies direct manager when compliance issues arise or are identified, when regulatory reports are delayed, and when other immediate action is required.
  • Archiving all documents, licenses and letters.

Job Requirements

  • Bachelor Degree in Pharmacy.
  • Good command of English language ( French is a plus).
  • Proven experience in Regulatory affairs with min of 2 – 3 years’ experience.
  • Current or previous experience in  CMC  is a plus.
  • MS Office Suite: Advanced user
  • ERP software: Basic user
  • Knowledge of laws, legal codes, court procedures, precedents, government regulations, executive orders, agency rules, and the democratic political process.
  • Knowledge of administrative and clerical procedures and systems such as word processing, managing files and records, stenography and transcription, designing forms, and other office procedures and terminology.

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