کارشناس امور تنظیم مقررات تولید

شرکت کوبل دارو تهران

منتشر شده 25 روز پیش

Job Description

  • Prepare CTD dossier for the locally manufactured products.
  • Cooperate in obtaining the HA approvals for the new APIs, excipients, and finished products.
  • Maintain the registration licenses for the APIs, excipients, and finished products and preparation of all the relevant regulatory submissions.
  • Make effective follow-ups with the HA on the open issues.
  • Handle all the assigned tasks for the PMQC.
  • Prepare bilingual artwork (outer box, leaflet).
  • Review all the relevant documents for the locally manufactured products in compliance with the applicable regulations.
  • Take all the necessary actions for the product release (document review, data logger handling, etc.)
  • Perform all the assigned tasks on TTAC (customs clearance for the APIs, finished product release, etc.).
  • Perform all the assigned tasks for the product sampling, including reference material registration.
  • Handle customer complaints.
  • Handle all the assigned tasks for the destruction process.
  • Cooperate in regulatory inspections (HA, partners).

Requirements:

  • PharmD; Bachelor's or Master's degree in Pharmaceutical Sciences, Chemistry, Biology or similar fields.
  • At least 3 years of experience in regulatory in the pharmaceutical industry.
  • Effective time management skills, and ability to handle multiple projects and tasks simultaneously.
  • Fluent in English.
  • Excellent organization skills and attention to detail.
  • Excellent skills in Microsoft Office.

Employment Type

  • Full Time

Details

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