Regulatory Affairs Specialist

Novo Nordisk Pars

  • Full Time

  • Tehran

      -   Tehran

Regulatory Affairs Specialist

Posted 5 Month ago

Job Description

-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

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