Regulatory Affairs Deputy Manager

Rougine Darou Tehran

Posted 21 days ago

Job Description

  • Studying registration documents.
  • Ensuring compliance with Iran’s Ministry of Health regulations and guidelines.
  • Gathering and preparing the documents for Iran’s drug list, brand registration, renewal, and variation.
  • Submitting the required documents for registration to Iran’s MOH.
  • Monitoring and following the registration process both with Iran’s MOH and related foreign companies.
  • Maintaining familiarity with imported and imported foreign company products.
  • Keeping up-to-date with changes in regulatory legislation and guidelines.
  • Obtaining marketing permission from Iran’s MOH according to the regulation.
  • Acting as a link between companies and Iran’s MOH, ensuring that products are manufactured and distributed in compliance with appropriate legislation
  • Writing comprehensible, user-friendly, clear Persian product information. leaflets and labels.
  • Ensuring that quality standards are met and submissions meet strict deadlines.

Requirements:

  • Preferably a Pharmacist - Doctor of Pharmacy (Pharm.D.).
  • At least 5 years of experience in regulatory, registration, and importation of pharmaceutical products.
  • A good understanding of the relevant Iranian MOH and quality framework.
  • Familiar with Dossier and CTD format.
  • Familiar with IDL and brand registration.
  • Familiar with the procedure of TTAC.
  • Good Command of English, both written and spoken.
  • High standard of accuracy and professionalism.
  • Time management skills to be able to meet deadlines.
  • Strong analytical skills, result-oriented, hardworking, team worker, and problem solver.
  • Excellent in interpersonal relations, self-motivation, loyalty, and well-recognizing.
  • Computer literacy.
  • Proficient in Word, Excel, and Outlook.

Employment Type

  • Full Time

Seniority

Details

Employment type

  • Full Time

Seniority

To see more jobs that fit your career