Regulatory Expert

Kimia Ara Tehran

Posted a year ago

Job

Company

Salary

Applicant Insights

Job Description

● Update local regulations and health authority requirements.
● Coordinate with foreign and domestic companies to obtain the necessary documents.
● Provide SOPs and implement pharmacovigilance based on PV guidelines.
● Review the contents of CTDs and preparing them for the review of the Ministry of Health.
● Product registration, license renewal, and submission of changes.
● Follow up on all assigned activities in the company and the Ministry of Health correctly and regularly.

Requirements

● Pharmacist (PharmD).
● One to two years of experience in the regulatory affairs of pharmaceutical products and medical devices.
● Good understanding of the laws of the Ministry of Health of Iran and related quality laws.
● Familiarity with IDL and required economic studies and brand registration.
● Familiar with Dossier and CTD.
● Familiarity with TTAC methods.
● Familiarity with drug monitoring instructions.
● Proficient in English, written and spoken.
● Proficient in Word, Excel, and Outlook.
● Excellent interpersonal relationships.
● Having flexibility, adaptability, spontaneity, and loyalty.
● Strong analytical skills, data-oriented, hard-working, and team-spirited.

Employment Type