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Pharmacist Assistant

Hikma Pharmaceuticals · Araçatuba

Junior 🇬🇧 English
Regulatory Affairs

Job description

About the role

Hikma Pharmaceuticals is seeking a Pharmacist Assistant to support regulatory and warehouse activities. The role involves preparing dossiers, managing product documentation, and ensuring compliance with health authority requirements.

Key responsibilities

  • Prepare, compile, and submit regulatory dossiers to health authorities in compliance with applicable requirements and timelines.
  • Coordinate regulatory activities throughout the product lifecycle, including dossier preparation, submission, response management, and variation filings.
  • Collect and verify required documentation from cross‑functional departments to ensure regulatory compliance.
  • Prepare and submit monthly and quarterly warehouse reports, especially for expired and psychotropic products.
  • Manage product destruction (incineration) files and obtain approval from relevant authorities.
  • Conduct periodic internal warehouse audits and prepare audit reports.
  • Ensure timely acquisition of import permits for imported products.
  • Participate in regulatory intelligence activities and contribute to continuous improvement of technical and regulatory processes.

Required profile

  • Doctor of Pharmacy degree (mandatory).
  • Minimum of one year experience in Regulatory Affairs.
  • High level of integrity, confidentiality, and adherence to procedures.

Required skills

  • Strong knowledge of Regulatory Affairs within the pharmaceutical industry.
  • Excellent written communication and interaction skills with health authorities.
  • Proficiency in Microsoft Excel and Microsoft Word.

Questions fréquentes

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Published 3 months ago

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Hikma Pharmaceuticals

Araçatuba