Regulatory Affairs Manager / Senior Regulatory Affairs Associate

Regulatory Affairs Manager, Senior Regulatory Affairs Associate, EU, MAA, Oncology, CTA,

Your new company

This distinguished bio-pharmaceutical company are looking for a candidate to join their team as either Regulatory Affairs Manager or Senior Associate. The candidate will be joining this biopharma’s tight-knit oncology team working on Regulatory Submissions for breakthrough CAR and T-Cell Receptor therapy research.

Your new role

You will oversee the managing and preparation of Regulatory submissions in the Oncology team. These submissions will be guided and directed by the European Regulatory guidelines. You will also be working on other Pre-Approval areas such as, Clinical Trial Applications (CTAs), Marketing Authorisation Applications (MAAs) and operating with cross-functional teams.

Main Responsibilities

  • Preparing of Regulatory submissions
  • Working to European regulations for submission to the EMA
  • Updating and supporting license changes e.g. Labelling and Artwork
  • Understanding of and working on Marketing Authorisation Applications (MAA)
  • Clinical Research work such as Clinical Trial Applications, and Regulatory Strategy
  • Working with cross-functional teams
  • Report into Associate Director

What you'll get in return

This will be in a position where not only will you have the opportunity for career development and progression, but you will also be able to work together with this company’s oncology treatment discovery team.

What you need to do now

If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.
If this job isn't quite right for you but you are looking for a new position, please contact us for a confidential discussion on your career.


Job type:
Cambridge or Uxbridge
Regulatory Affairs
Closing date
07 Oct 2019
Apply Now

Talk to a consultant

Talk to Kim Hahne, the specialist consultant managing this position, located in London City

4th Floor, 107 Cheapside

Telephone: 02034650053

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