Maternity Cover - Regulatory Associate, Publishing

  • Department: Regulatory Affairs
  • Location: Harlow, Essex
  • Education Level: University degree
  • Employment Type Level: Full Time
  • End Date: 20-Apr-2018

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Overview

Want to be proud of the organisation that you work for? Teva UK Limited is one of the largest pharmaceutical companies in the UK.

Teva is a leader in UK healthcare and a big player on the world stage, supplying a wide range of medicines to the UK health service and across the globe in a wide range of disease areas. Millions of patients throughout the UK benefit from our medicines with tablets and capsules supplied by us taken by patients all around the UK.

We are currently looking for a talented individual to join us - people who believe in the things we do – people who are enterprising, motivated, and have a “can do, will do” attitude; people who are striving for excellence and whose ambition matches ours.


We are currently searching for a Regulatory Publishing Specialist to join an established Central EU Regulatory Submissions team to provide maternity cover for 9 months.

Within this role you will be responsible for publishing regulatory documents for electronic 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.

Skills & Experience

MINIMUM QUALIFICATIONS:
  • Understanding of EU and ICH publishing regulations and guidelines.
  • Proficiency in publishing regulatory documents and using regulatory e-submission software ideally has experience working with Liquent’s Publisher and is certified.
  • Proficient with (ISI Toolbox) as well as Microsoft Office Suite (Word, Excel, PowerPoint, Office), Adobe Professional.
  • Ability to work independently with minimal supervision
  • Possess strong written and verbal communication skills and advanced word processing and formatting.
  • Ability to multi-task, pay close attention to detail, and follow projects through to completion.
  • Excellent organizational, prioritization, and planning skills.

EDUCATION REQUIREMENTS

  • Degree educated or above.

Main Responsibilities

1. The candidate shall ideally have experience with electronic CTD (eCTD) publishing software, as well as an understanding of regulations and guidelines to ensure eSubmissions compliance. 
2. The candidate will be implementing submission standards where applicable.
3. The candidate will be responsible for ensuring that all final electronic deliverables meet current regulatory electronic document requirements and guidance. 
4. Candidate will prepare submissions and applications in the Common Technical Document (CTD) in electronic formats with some additional paper requirements as appropriate. 
5. The candidate must also be detail-oriented, thorough, and methodical. 
6. The candidate shall establish and comply with standard operating procedures for publishing regulatory submissions.