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Senior Regulatory Affairs Manager

  1. South East
  1. Permanent
£60000 - £70000 per annum, Benefits: Bonus + Benefits Package
  1. Drug Safety / Pharmacovigilance
Date Posted13 Sep 2019
Do you relish the opportunity to work with a leading UK based Biologics manufacturer?  If yes, then this is the position for you!

Our biotech client, with manufacturing facilities just outside London, is currently investing significantly in their manufacturing programme.  This state-of-the-art facility houses high-technology and next-gen processes to produce drugs that are distributed throughout the Globe. The site is easily reachable by two major airports and has excellent transport links throughout.

The client is currently seeking the expertise of a Senior Regulatory Affairs Manager due to their rapidly growing team!

In this role you will be responsible for the line management of a team of permanent staff members, helping to manage their goals, objectives and training needs. You will oversee all licensing activities throughout the product range. Along with this you will ensure proper process and systems are in place to manage all regulatory activities related to drug licenses.

You will have the following experience/qualifications:
  • 7-10 years experience within Regulatory Affairs
  • Demonstratable experience with managing business critical and complex drug development projects and licensing activities
  • Broad knowledge of regulatory filing strategies
  • Demonstrable team leadership skills
  • Project Management skills are desirable
  • Substantial experience in obtaining and maintaining product licenses worldwide and obtaining clinical trial authorisations in key markets (EU, US )
  • Substantial knowledge of current drug regulations in key markets (US, EU,)
  • Substantial experience of dealing and negotiating directly with Health Authorities in key markets (EU, US)
This is the ideal role for a Regulatory Affairs professional looking to take the next step of their career into management.

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