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Regulatory Affairs Manager

Posted 03/09/2021
£124,800 per annum

Our Client are looking for an experienced professional to work in one of the largest Biotechnology company in the world. We are looking for someone that will be joining the Oncology Regulatory team, part of Regulatory Affairs function in Europe.

The team will be responsible for leading the European regulatory strategies and submissions for development and marketed products from first in human clinical trials to marketing authorisation and throughout the product lifecycle.

  • Degree Qualified in a scientific discipline.
  • Strong experience in regional regulatory environment
  • Proven track record of developing and executing regional regulatory strategy.
  • Ability to understand and communicate scientific/clinical information.
  • In depth understanding of the registration procedures in region of MA, post approval changes, extensions, and renewals.
  • Clinical Trial Application
  • Marketing Authorisation Applications
  • Post Approval Changes, extensions, and renewals
  • Strong submission experience

Further Details please contact Fandi Hatib on 01727 817600 or email

Achieva Group Limited

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