Regulatory Affairs Manager - EU MAA's

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

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Overview

Have you got experience in European Regulatory Affairs, with a Life Science or similar degree? Would you like to work in the varied and fast-paced environment of licensed-in generic products? If so, we're looking for someone like you...  

Teva is recruiting a Manager 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 for a wide variety of products and dosage forms for Retail use registered via the Decentralised or Mutual Recognition Procedures.

You will primarily work with third party partners, specifically on European projects.  You will be responsible for reviewing the technical content of third party dossiers against EU regulatory requirements for generic products.  In addition you will prepare and submit high quality regulatory dossiers and post marketing documentation. An active role will be taken in the project team evaluating data and completing reports, MAA modules and response documents, before submission of the final documentation to the National Competent Authorities.

Reporting to a Senior Manager, 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 licensed-in Regulatory Affairs, there will be the opportunity for exposure to a wide range of regulatory issues and procedures.

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.

Skills & Experience

To be considered for this role you will have the below skills and experience:

  • Degree (or equivalent) in Pharmacy/Chemistry or Life Sciences related subject
  • Substantial industrial experience within Regulatory Affairs including practical experience of European 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 as part of the in-licensing decision making process
  • Work closely with third party partners in order to prepare and submit high quality regulatory dossiers including 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 consistently ensuring that internal and external deadlines are met
  • Line management of a Regulatory Affairs Associate may be part of the role, for the right candidate

Job Description

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