Senior Regulatory Affairs Associate - Russia

.We are recruiting for a 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.

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)QualificationsExperience 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.