PRAHS

Returning Candidate?

2017-42944

2017-42944

Title 
Manager, EU Regulatory Affairs
Job Locations 
-
United Kingdom
Posted Date 
9/29/2017

More information about this job

Overview

Manager, EU Regulatory Affairs

London

 

Who we are

 

At PRA, we don’t make our 14000+ people great. It’s the other way around. As we have grown to a top-5 CRO, we have maintained the feel of a small company, dedicated to collaboration and passion for what we do.

 

We always have a desire to keep seeking new and better ways to operate. We don’t settle for the same old ways. Our passion for improving patient lives worldwide permeates all that we do.

 

Working fully embedded within one of our pharmaceutical clients, with the support of PRA right behind you, you’ll be at the heart of our client’s innovation.

Responsibilities

Position overview

 

The Manager of EU Regulatory Affairs (RA) is aligned to the client’s portfolio of licensed products. The manager is responsible for the global RA maintenance of assigned products working in collaboration with affiliate companies across Europe.

 

Providing functional input across a global regulatory team the Manager of EU Regulatory Affairs will plan, manage and execute regulatory activities on licensed products.

 

The Manager may be assigned as Global Regulatory Lead and as such will have global oversight of assigned products (to include Emerging Markets) in conjunction with planning, coordinating and managing all regulatory activities in a timely manner.

 

Other responsibilities will include:

 

  • Submission of variations, renewals, line extensions, responses to request for further information, Marketing Authorisation Applications in further countries
  • Drive submissions through the approval procedure (MRP, DCP, CP) in the EU
  • Working with project and functional teams to ensure that data generated is appropriate and will be compiled and submitted in accordance with EU requirements
  • Direct communication with Regulatory Authorities to facilitate productive dialogue on assigned products
  • Liaise with external companies with respect out-licensing supporting activities as required
  • Review and coordination of PSUR submissions
  • Handling of regulatory documents in the electronic document management system
  • Regulatory assessment of change requests

 

Qualifications

You are

 

A team worker with the ability to influence in order to achieve objectives. You will have excellent organisational skills, flexibility and attention to detail along with a mind-set towards adherence to timelines.

 

Here at PRA we want our employees to succeed and ensure that they are set up for this success through constant training, development and support. To enable success in this position you will have:

  • Experience in global Regulatory Affairs maintenance work
  • Experience in submission of new marketing authorisation applications
  • Significant knowledge of eCTD/CTD dossiers
  • A degree in pharmacy/life science or similar
  • Experience in interactions with European Regulatory Authorities in relation to all aspects of regulatory activities

 

Your health, your family, your career, your money — the things that matter to you, matter to us. The benefits of PRA just get better and better.

 

PRA Health Sciences is an Equal Opportunity Employer. We welcome and encourage diversity in the workplace.

 

For more information please visit our website: www.prahs.com

 

 

Options

Share on your newsfeed

Connect With Us!

Not ready to apply? We get it! Click here to stay in touch for future opportunities, events and other happenings!