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Regulatory Affairs Professional - CTA/ EU-CTR (flexible location UK/EU)

Employer
Parexel
Location
United Kingdom
Salary
Competitive
Start date
25 May 2024
Closing date
24 Jun 2024

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Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

We are currently looking for Regulatory Affairs Professionals experienced in Clinical Trail Applications (CTAs) under EU-CTR directive. You can join us or our client dedicated projects and act as a Regulatory Affairs Consultant or Regulatory Affairs Senior Associate.

This role can be based in either UK or UE (home/office based).

In this role you will provide leadership in all regulatory and submissions related aspects of the clinical trial, you will be the main client contact and will be responsible with delivering submission specific milestones, while also providing guidance to the client on submissions strategies. You will be involved in EU CTR consulting and in operational aspects of EU CTR implementation and take on the role of Clinical Trial Submission Coordinator ensuring transversal collaboration between departments, working towards the delivery of all submissions of complex large clinical trials.

Ideal candidate will possess:
  • University degree in a science discipline
  • Background in clinical trial management
  • 2-5 years of experience in Regulatory Affairs
  • Good level of knowledge of the Clinical Trail Submissions on a local and regional level
  • Working knowledge of submissions under EU CTR direcitve
  • Project Management experience
  • Solid analysis and synthesis capability; Solution-oriented and problem-solving skills.
  • Customer-oriented and autonomous
  • Fluency in English is a must along with the local language.

#LI-REMOTE

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
GB

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