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.
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