Regulatory Affairs Officer

  • Department: Regulatory Affairs
  • Location: Harlow, Essex
  • Education Level:
  • Employment Type Level: Full Time
  • End Date: 29-Sep-2017

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Overview

Have you got experience in UK Regulatory Affairs, with a Life Science or similar degree? Would you like to work in the varied and fast-paced environment of generic new submissions, and take your career to the next level? If so, we're looking for someone like you...  

Teva is recruiting a Regulatory Affairs Officer to work within the UK Regulatory Affairs Team, based at our office in Harlow, Essex.  You will work in a large team of regulatory affairs professionals, working in a key hub of Teva’s Regulatory Affairs organisation. Over 200 people, across multiple functions, are based in Harlow, working collaboratively for Teva, one of the biggest pharmaceutical companies in the UK and among the top 15 pharmaceutical companies in the world.

Skills & Experience

To be considered for this role you will be educated to BSc (Hons) level (or equivalent) and should ideally have knowledge of regulatory affairs and the pharmaceutical industry, ideally with good knowledge of EU regulatory procedures and requirements. Excellent verbal and written skills are essential as communication will play a key part in this in this role.

If you have knowledge of Regulatory Affairs and are looking to move your career to the next level in a fast paced and dynamic environment, then we’d love to hear from you.

Main Responsibilities

·         Prepare, compile, review and submit appropriate high quality regulatory dossiers, post-approval changes (variations, renewals, PIQU submissions) and responses to Health Authority questions in accordance with in-house standards and current legislation

·         Ensure approvals are secured within the stipulated timelines for designated projects

·         Maintain registration documentation and associated electronic databases, in line with in-house procedures

·         Provide regulatory support and product information for all internal and external customers, stakeholders and TEVA project teams

·         Prioritise, plan and monitor allocated projects against defined timelines

·         Maintain and develop awareness of current/pending regulatory legislation and guidelines

·         Identify and initiate areas for process improvement, and manage changes as required