Regulatory Affairs Coordinator

Posted a year ago

Job

Company

Salary

Applicant Insights

Job Description

Your responsibilities include, but are not limited to:

Following and being updated for the local regulations and health authorities’ requirements.
Updating the company and related departments with the latest regulations of the MOH (Ministry of Health).
Coordinating with foreign companies and local manufacturing sites to obtain necessary documents.
Reviewing the CTDs contents and if it is an under-licensed product.
Preparing the forms and documents to be sent to MOH.
Product registration, license renewal, and variation submission.
Visiting MOH persons regularly to follow up on pending tasks with them.
Following all the companies' activities in MOH properly and regularly.
Translating the needed documents to be submitted to MOH.
Preparing the bilingual (English-Persian) patient leaflet and packing materials.

Requirements

PharmD, or Bachelor's or Master's degree in Medical, or Paramedical Sciences.
At least 3 years of experience in the regulatory field, registration, and importation of pharmaceuticals.
Familiar with CTD, CPP, COA, Performa, Invoice, GMP, and DIAF.
Familiar with regulations, instructions, and policies of FDA, registration process and IDL, TTAC, IRC, and quotation and planning systems.
Good understanding of the relevant Iranian MOH and Quality Framework.
Familiar with pharmacovigilance guidelines.
Proficient in Word, Excel, and Outlook.
Good command of English, writing, and speaking.
Interpersonal relations skills.
Result-oriented, hardworking, team worker, problem solver.
Highly detailed-oriented.
Able to work under pressure.
Time management skills to meet the deadline.

Employment Type