Senior Regulatory Affairs Officer - EU MAA's

  • Department: Regulatory Affairs
  • Location: Harlow, Essex
  • Education Level: University degree
  • Employment Type Level: Full Time
  • End Date: 27-Oct-2017

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Overview

Do you have experience in European Regulatory Affairs? Would you like to work in the varied and fast-paced environment of generic products? If so, we're looking for someone like you...  

Teva is recruiting a Senior Regulatory Affairs Officer to work within the European 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.

The focus of the role will be on the submission of new generic Marketing Authorisation Applications (MAAs) for a wide variety of products and dosage forms for retail use, registered via the Decentralised or Mutual Recognition Procedures. This high profile role will mean you working with third party partners, portfolio, local business units and a whole host of other stakeholders.   Due to the varied nature of the role, there will be the opportunity for exposure to a wide range of regulatory issues and procedures.  

Skills & Experience

  • Degree (or equivalent) in Pharmacy/Chemistry or Life Sciences related subject
  • Significant industry experience within Regulatory Affairs including practical experience of European MAA submission procedures
  • A good understanding of European regulatory requirements and guidelines for generic products
  • Previous CMC experience (or a demonstrated technical aptitude) and familiarity with the scientific content of the dossier
  • Previous supervisory or mentoring experience may be an advantage

Main Responsibilities

  • Review the technical content of third party dossiers against current regulatory requirements
  • Work closely with third party partners in order to prepare and submit high quality regulatory dossiers including initial Marketing Authorisation Applications, response to Health Authority questions and critical pre-launch post-approval variations
  • Be able to understand complex issues and clearly communicate issues to customer base 
  • Represent team during strategic and technical discussions, including participating in project teams
  • Enjoy the challenge of working under pressure whilst ensuring that internal and external deadlines are met
  • Line management of a Regulatory Affairs Officer may be part of the role, for the right candidate

If you have significant EU Regulatory Affairs experience and would like to work in a fast paced and dynamic environment, then we’d love to hear from you!

Job Description

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