Regulatory Submissions Associate

  • Department: Regulatory Affairs
  • Location: Harlow, Essex
  • Education Level:
  • Employment Type Level: Full Time
  • End Date: 11-Aug-2017

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Overview

Teva currently have an excellent opportunity for a Regulatory Publishing Specialist to join the established Central EU Regulatory Submissions team on a permanent basis. Within this role you will be responsible for publishing regulatory submissions according to current eCTD and NeeS validation criteria and ICH Standards.  Our team is currently dedicated to EU Gx submissions, including Initial Marketing Authorisation Applications as well as any associated maintenance and post approval tasks.

 

About us…

We have the largest medicine cabinet in the world, and now we are shifting our mind-set from illness and disease management to overall health, looking at people through health, not only through illness.

We are going further than ever before; beyond the pill into integrated solutions, disease management, prevention and overall wellness.

If this is a future you want to be a part of, read on…

 

Location

Over 250 people, across multiple functions are based in Harlow, working collaboratively for Teva, one of the biggest pharmaceutical companies in the UK.  We estimate that every second of every day over 350 tablets and capsules are taken by patients in the UK, so if you join us you’ll be working for the biggest supplier of medicines to the NHS.

With our office right by Harlow town station, we've got great transport links into London and beyond, and there's parking on site - a definite bonus! Plus we’ve got great facilities on site for our employees.

Skills & Experience

You will be educated to degree level (or equivalent) and should be proficient in publishing EU regulatory submissions and using regulatory e-submission software. Experience with Microsoft Office and Adobe will be essential, along with the ability to research and review content effectively. The ability to pay close attention to detail whilst following projects through to completion will be essential. 

Main Responsibilities

  • Experience with electronic CTD (eCTD) publishing software, as well as comprehensive knowledge of regulations and guidelines to ensure eSubmissions compliance would be advantageous but training will be provided.
  • Experience in implementing full submission standards where applicable and ability to provide QC review of said standards, such as the hyperlinking and bookmarking of regulatory documents advantageous but training will be provided.
  • The candidate will be responsible for ensuring that all final electronic deliverables meet current regulatory electronic document requirements and guidance.
  • Candidate will prepare submissions and applications in the Common Technical Document (CTD) in electronic formats with some additional paper requirements as appropriate.
  • The candidate must also be detail-oriented, thorough, and methodical.
  • The candidate shall establish and comply with standard operating procedures for publishing regulatory submissions.