Regulatory Affairs Manager, Virology (EU)

  • Hays Life Sciences
  • Uxbridge, UK
  • 01 Nov, 2020
Full Time Consultant

Job Description

Regulatory Affairs Manager, Regulatory Submissions, Virology, CTAs, Complex Variations, EU, PIPs

Your new company
This American Multi-National biopharmaceutical company are looking for someone to join their Virology team as Regulatory Affairs Manager. Being a part of the Regulatory Affairs Virology team gives you the opportunity to work across an innovative and fast-paced portfolio, across life-threatening diseases. This will be based in the company's Uxbridge or Cambridge site.

Your new role
By joining the Virology team as Regulatory Affairs Manager, you will get the opportunity to work on life-threatening diseases such as HIV, Hepatitis, and Emerging Viruses. This work will mainly be across Centralised European markets as well as Canadian, Australian and Brexit-related activities. You will be expected to cover new early stage submissions such as CTAs as new development products come through, as well as work across life-cycle maintenance for marketed products. The life cycle maintenance work will be particularly complex, submitting Clinical, Labelling and Type II variations, Line Extensions, and Post-Market Paediatric submissions. You will act as product lead and take full ownership across submissions that come your way, so previous experience in this is extremely desirable.

Main Responsibilities

  • Technical Regulatory Affairs strategy development
  • Initial Submissions across: CTAs, MAAs, PIPs, Labelling
  • Post-Marketing Submissions across: Complex Variations, PIPs, Line Extensions, Renewals
  • Independent product ownership
  • Strong Labelling knowledge
  • Communication with cross-functionally
  • European (CP) market submissions (Mainly)
  • Canada, Australia, Brexit market submissions (Additionally)



What you'll get in return
You will get the opportunity to work with a top 10 pharma across an extremely innovative product portfolio in a growing team. You will be compensated generously for the high level of responsibility of the role and have ample opportunity for progression internally.

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.
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