کارشناس رگولاتوری

شرکت کوبل دارو تهران

منتشر شده 10 روز پیش

Job Description

  • Cooperate in obtaining the HA approvals for the new products.
  • Maintain the product licenses (renewals, variations) and preparation of all the relevant regulatory submissions.
  • Prepare bilingual artworks (outer box, leaflet).
  • Review all the relevant documents for the importation in compliance with the applicable regulations.
  • Take all the necessary actions for the product release (document review, labeling, data logger handling, etc.)
  • Perform all the assigned tasks on TTAC (customs clearance, 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

  • Bachelor's or Master's degree in Pharmaceutical Sciences, Chemistry, Biology, or similar fields.
  • At least 3 years of experience in the regulatory field 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.

برای مشاهده‌ی شغل‌هایی که ارتباط بیشتری با حرفه‌ی شما دارد،