-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.
Requirements
-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