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Regulatory Affairs Specialist Hertfordshire

Permanent / Hertfordshire, UK

£45,000

Regulatory Affairs Specialist - Hertfordshire £45,000

Due to expansion, a fantastic opportunity has arisen for a Regulatory Affairs Executive with a leading pharmaceutical company. This is a permanent position, office-based in Hertfordshire. The aim of this role is to deliver and maintain competitive licences for UK/Ireland/Malta commercial brands and meet Regulatory Compliance Requirement for defined product and project responsibilities.

Role responsibilities:

  • Ensure timely submission of all licensing applications and compliance with UK/Ireland/Malta regulatory requirements
  • Ensure clinical trial applications are filed to target and amended appropriately
  • Assure appropriate standards and policies are maintained for all technical aspects of the company's regulatory activities
  • Provide regulatory input to stock and supply issues
  • Liaise with Operations to manage pack changes and ensure labelling compliance
  • Proactively manage the regulatory process and effectively negotiate with regulatory agencies to provide rapid regulatory approvals with competitive labelling
  • Develop professional working relationships with assessors and administrative staff within the regulatory agencies
  • Prepare high quality regulatory applications and regulatory responses for UK/Ireland/Malta (including input to responses for European applications

Candidate requirements:

  • Educated to degree-level in a life science discipline
  • At least 2 years experience in Regulatory Affairs in the UK
  • Strong post-approval experience
  • Strong National (UK/Ireland) experience
  • Excellent written and spoken English
  • Eligible to work in the UK

 

If you have difficulty in applying, have any questions or you cannot find what you are looking for please contact us on 0044 (0) 207 421 0000 or email info@life-science.co.uk. We regard all communication and correspondence as confidential. Full job descriptions are available on request.

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About us

Resourcing Life Science is a specialist recruitment agency, providing career advice and employment opportunities within the Pharmaceutical, Biotechnology, Medical Devices and Clinical Research industries across the globe.

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info@life-science.co.uk

0044 (0) 207 421 0000

Resourcing Life Science Ltd.
226 High Road
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