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Senior Regulatory Affairs Associate - Russia

Employer
Parexel
Location
Moscow, Russia
Salary
Competitive
Start date
8 Apr 2021
Closing date
8 May 2021

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Discipline
Clinical Research
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

Job Description

.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.
  • Why Work at Parexel

    There are pivotal moments in every career: Sharing new treatments. Improving processes. Delivering life-saving advances. The people who succeed are the ones who make the journey go further and faster every time. What if you had a partner to support you as you reach the next level in your professional path? A partner who believes a collaborative environment is key to achieving your goals? A partner who is dedicated to your health and wellness so you can help make a difference in the lives of millions worldwide?

    That's Parexel. We're a diverse team of professionals focused on one goal: getting treatments into the hands of those who need them most. Working together, the results we bring to our clients and the opportunities we bring to our team get better with every step.

    How can we help you on your journey? Find your path, and learn more on LinkedIn, YouTube, Facebook, Twitter, and Glassdoor.

    Company

    parexel

    When you join us, you’re joining a team that sees everything they do as an opportunity to transform the world for patients everywhere. When our employees bring their many perspectives together to tackle a new challenge, there’s no limit to what they can accomplish. Through it all, at the center of all we do, is a patient whose life could change – forever. And together, we’ll do it With Heart™.

    How to describe Parexel’s culture in one word: 

    Henry

     

     

    Working With Heart™ - Christina's perspective:

    Working With Heart™ - Christina's perspective:

     

    Careers Blog | Our Culture | Diversity, Equity & Inclusion | Benefits | Our Hiring Process

    Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help lifesaving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory, and therapeutic expertise, our team of more than 21,000 global professionals works in partnership with biopharmaceutical leaders, emerging innovators, and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere. 

    Company info
    Website
    Telephone
    +44 1895 238000
    Location
    The Quays
    101-105 Oxford Road
    Uxbridge
    Middx
    UB8 1LZ
    United Kingdom

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