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Regulatory Affairs Consultant, MA transfer

Employer
Parexel
Location
Bucharest, Romania
Salary
Competitive
Start date
14 Mar 2019
Closing date
28 Mar 2019

View more

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

Job Details


As a Consultant you will part of a dedicated team to support one of PAREXEL Consulting's partnership projects.
  • You will have the opportunity to be involved in pivotal life cycle maintenance operations, with a focus on managing CMC related changes closely related to MA transfers across the world.
  • Activities will include managing a region or several regions depending on the project needs, and checking the quality of submission packages before these go out to the client.
  • Tasks may also involve strategizing with the client and project team with submission strategy with the country teams for specific submissions.
  • This role also encompasses project leadership - accountability for overall quality and timelines for submission.
  • The role offers an exciting opportunity to work with colleagues and clients directly both locally and globally, on a variety of products.


Qualifications

Key requirements:

  • Minimum of a Bachelor's Degree in a Scientific or Technical Discipline
  • Several years of experience in an industry-related environment
  • Good understanding of performing the above regulatory tasks on a regional/global level
  • Strong project Management skills
  • Strict adherence to timelines (both internal and HA deadlines)
  • Proactive approach and excellent communication skills
  • Fluent English

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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