-Implementation and supervision of health authorities and regulations in Novo Nordisk Pars
-Ensures that current registration requirements are available, communicated and implemented
-Compiles and submits registration files for new products
-Follow-ups with the Iranian Ministry of Health on files review and ensures timely submission of additional documentation requested
-Compiles and submits renewal files and updates of approved products
-Ensures registration information system (RIMS) is updated according to the latest approved regulatory data in territory
-Handles all labeling update processes and sends covering letters to Regulatory Operations in HQ.
-Proof-reads labeling items and approves along with the local RA manager
-Support local RA manager in all the GMP, GDP, GXP and external inspection by competent
-Supports the local RA manager for authorization of distribution for imported shipment based on local regulations
*The position is based in Tehran, Iran and is on local term and conditions.
-BSc degree in Pharmaceuticals from a reputable institute
-Experience within Regulatory Affairs and/or Quality Assurance is a requirement while the candidate should be familiar with Product Registration and MOH Regulations
-The candidate should be a pharmacist and having experience in Pharmaceutical Industry would be advantage
-Ability to establish a high-quality cross-functional communication is also important, as this unit is naturally involved with all other units
-You should be able to demonstrate the ability to work on your own initiative and have excellent customer service and good IT skills
-A good understanding of the relevant Iranian Regulatory and Quality framework is required
-Good communication skills, time management and high attention to details and accuracy are also very important parts of this role
-Fluency of Farsi/English is required
*Traveling is part of this position
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Novo Nordisk Pars
Novo Nordisk is a world leader healthcare company in diabetes care, having the broadest diabetes product portfolio in the industry, including the most advanced products within the area of insulin delivery systems. In addition, Novo Nordisk has a leading position within areas such as haemostasis management, growth hormone therapy and hormone replacement therapy. Novo Nordisk manufactures and markets pharmaceutical products and services that make a significant difference to patients, the medical profession and society.
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