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Senior Regulatory Affairs Associate - Russia Moscow

Moscow
2021-05-30 04:21:14
Senior Regulatory Affairs Associate - Russia Moscow
.We are recruiting for 2 x Senior Regulatory Affairs Associate to join our Clinical Trial Regulatory Services EU Consulting team in Moscow, Russia.This is an ideal role for someone who would excel working in a fast-paced international team. One will work on CTA activities and the other will work on MAA acitivies.

It is essential that you are Fluent in English and Russian to apply for this role!

Job Responsibilities:
• Preparation of EU submissions packages (LCM activities - variations, renewals, etc.) for Russia
• Provide regulatory support and perform regulatory activities within emerging markets team. This will include meetings between client, local contacts & the distributors, performing day to day regulatory activities relating to labelling, type I, type II variations, NDAs / MAA applications, updating trackers, coordinating activities with distributors/affiliates and client.
• ; Prepartion of new drugs registration process in local Russian market (including the EuroAsian... Economical union)
Qualifications
Experience Required:
• Experience in the whole process of Marketing authorization applications preparation (in Russia, including EMEA Economical union procedures),
• Deep knowledge of the legislation and requirements of the Registration process:

Qualifications Required:
• Few years of experience in Regulatory Affairs and Clinical Research in Pharma or CRO.
• A degree in Life Sciences. Advanced degree will be an asset
Moscow Russia
Senior Regulatory Affairs Associate - Russia Moscow Parexel Moscow
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