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International Markets Regulatory Affairs Specialist

Abdi Ibrahim Pharmaceuticals · Istanbul

🇬🇧 English
MS Office

Job description

About the role

Abdi İbrahim, a leading Turkish pharmaceutical company, is seeking an International Markets Regulatory Affairs Specialist to join its Regulatory Affairs team in Maslak, Istanbul. The role focuses on managing regulatory submissions and ensuring compliance across a wide range of international markets.

Key responsibilities

  • Prepare and submit marketing authorization dossiers to health authorities in target countries according to defined timelines.
  • Handle renewal dossiers and follow‑up on variation applications.
  • Coordinate responses to deficiency letters and maintain accurate documentation.
  • Monitor national and international regulations, ensuring ongoing compliance.
  • Provide regulatory guidance to internal departments and archive all product‑related correspondence.

Required profile

  • Bachelor’s degree in Pharmacy, Chemistry, Biology, Chemical Engineering or Molecular Biology.
  • Minimum two years of regulatory affairs experience in international markets.
  • Strong written and verbal English skills; additional language (Russian or French) is a plus.
  • Excellent analytical, problem‑solving and organizational abilities.
  • No military obligation for male candidates.

Required skills

  • Proficiency with MS Office applications.

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Published 2 ay önce

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Abdi Ibrahim Pharmaceuticals

Istanbul