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Regulatory Officer Oxford United Kingdom,  

PSI (company)


Posted on : 22 March 2017

Project Description

Description:
  • If you are keen to administer the clinical trial approval process, act as the crucial link between the company and regulatory authorities, share your knowledge of local legislation and regulatory requirements, and be involved in something new, outstanding and challenging, this job opportunity is perfect for you.
  • If you value high quality standards, transparent communication lines, excellent opportunities for professional development, well-established infrastructure and an energetic environment, join our company.



Responsibilities:
  • Liaising with clinical project teams to procure documents required for regulatory & ethics submissions 
  • Preparation of regulatory and ethics committee submission dossiers 
  • Tracking regulatory project documentation flow and progress reporting 
  • Tracking changes/amendments to legislation requirements related to clinical research 
  • Maintaining the database of regulatory requirements 
  • Communication point for ethics committees and regulatory authorities 
  • Ensuring accurate and timely reporting to ethics committees and regulatory authorities; 
  • Communication line for clinical Project Teams and company support services on regulatory matters 
  • Delivering regulatory-related training, as required 



Qualifications:
  • Technical expertise in managing regulatory aspects of clinical studies in the UK 
  • At least two years  experience in Regulatory Affairs for clinical research and knowledge of local regulatory environment 
  • University degree in Life Sciences or Pharmacy 
  • Excellent command of English (spoken and written) 
  • Excellent communication, planning and organizational skills 
  • Demonstrated ability to multi-task and work effectively in a fast-paced environment 
  • Proficiency in standard MS Office applications

Locations

UK OXFORD

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