Regulatory Affairs Manager

Kar o Andisheh Tehran

Posted 3 months ago

Job Description

  • Supervise the regulatory team.
  • Create and manage effective communication and close collaboration with MOH
  • Keep up-to-date with the latest news in MOH, syndicates, and the pharmaceutical industry.
  • Prepare and complete regulatory documentation for submission to MoH.
  • Support the maintenance of regulatory files in compliance with regulations and standards applicable to company products.
  • Manage and conduct pharmacovigilance activities.
  • Develop and execute strategies related to organizational goals aligned with MOH to meet objectives.
  • Manage and conduct GDP activities including quality risk management of GDP deviations for all imported products.
  • Monitor and control all necessary documents and release of the batches of imported pharmaceutical products.
  • Track variations and changes in production lines for submission to regulatory authorities.

Requirements:

  • PharmD (Pharmacist).
  • At least 2 years of managerial experience in related fields.
  • Familiarity with the principles of GXP (GLP, GDP, GSP, GMP, etc.) based on the international GMP guidelines.
  • Strong communication skills.
  • Able to work under pressure and tight deadlines.
  • Fluent in English.
  • Capable of traveling and site visits.
  • Familiar with Iran FDO regulation and TTAC system.

Employment Type

  • Full Time

Seniority

Details

Employment type

  • Full Time

Seniority

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