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Regulatory Officer - Germany  

Company managed [?] Still accepting applications
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Posted on : 08 March 2017

Project Description


REGULATORY OFFICER 
If you are keen to administer clinical trial approval process, share your knowledge of local legislation and regulatory requirements, and be involved in something new, outstanding and challenging, come to our company  and start your exciting professional journey with us!



REQUIREMENTS
  • Technical expertise in managing regulatory aspects of clinical studies in Germany/Austria/Switzerland and EU 
  • At least 2 years of prior industry experience in Regulatory Affairs Germany/Austria/Switzerland/EU and knowledge of the local regulatory environment 
  • Experience in clinical trials with gene therapy and medical devices is a plus 
  • Excellent communication, planning and organizational skills 
  • Excellent command of English (spoken and written) 
  • Higher education in life sciences, pharmacy or medicine 
  • Computer proficiency 
  • Ability to work hard under pressure and face challenges 


RESPONSIBILITIES

REGULATORY AFFAIRS
  • Liaising with Project Teams to procure documents necessary for regulatory and ethics committee submission and preparation of regulatory and ethics committee submission dossiers, including import and export licenses 
  • Tracking regulatory project documentation flow and progress reporting 
  • Tacking changes/amendments to legislative acts pertaining to clinical trials in Germany/Austria and timely notification of all parties involved 


COMMUNICATION
  • Primary or secondary contact person for ethics and regulatory authorities 
  • Primary contact for Project Teams on all regulatory issues 
  • Back-up communication line for the customer and the sponsor (if not the same entity) for all regulatory issues 
  • Back-up contact for co-contractors, subcontractors, and third-party vendors (regulatory issues) 


QUALITY CONTROL
  • Primary and secondary responsibility for developing and implementing corporate quality control tools and techniques pertaining to Regulatory Affairs 
  • Primary responsibility for review of investigational product release-enabling documents 


TRAINING
  • Primary or secondary responsibility for training company employees in regulatory issues