Regulatory Affairs CTA Specialist

Job type:
permanent
Start:
07/2015
Duration:
n.a
From:
Real Staffing
Place:
Cambridge
Date:
03/04/2015
Country:
flag_no United Kingdom

Project description:
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This project is archived and not active any more.
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Regulatory Affairs Specialist: Global Pharmaceutical Company

Location: Cambridge with potential for some home working

Salary: £40,000 - £45,000 + excellent package

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KEY RESPONSIBILITIES
  • Management and support of Clinical Trial Applications
  • Building and maintaining relationships with other functions within the company
  • Maintaining and development of Regulatory Systems and administrative activities
  • Maintaining cGxP and H&S knowledge applicable to the job
  • Other duties as required


Management of Clinical Trial Applications
  • Provide regulatory advice to other stakeholders involved in clinical trials
  • Liaise with Health Authorities or local contacts in regard to CTA submissions
  • Coordinate, compile and submit clinical trial applications (CTAs) as agreed with the Clinical Department ensuring appropriate internal processes are followed
  • Ensure all CTAs are made within the agreed timeframes
  • Provides oversight of appointed CRO/CRA to ensure appropriate processes are adhered to
  • Liaise with all the necessary personnel to keep them informed of progress, actions and activities, as necessary


Education/Qualifications Required:

Graduate, postgraduate or equivalent, ideally in a scientific or healthcare discipline.

If you are interested in finding out more information please send your updated C.V to Natalie Hopkins at n.hopkins(a)realstaffing.com or call for more opportunities