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Regulatory Affairs Specialist - Austria  

PSI (company)


Posted on : 27 March 2017

Project Description

We are looking for professional qualified and enthusiastic candidates to take up a full-time position of a Regulatory Affairs Specialist to be involved in regulatory process for clinical trials and provide administrative support to the company’s Regulatory Affairs Department in our office.

  • College or University Degree, Life science degree is a plus 
  • Prior experience in clinical research or medical/health industry 
  • Native German, excellent English (written and spoken) 
  • Proficient user of standard MS Office applications 
  • Attention to detail 
  • Good communication, organizational and time-management skills 
  • Demonstrated ability to multi-task and work effectively in a fast-paced environment 

The scope of responsibilities will include:
  • Communication line for clinical project teams and company support services on regulatory matters 
  • Preparation of draft project-specific regulatory/ethics dossiers 
  • Document management including preparation, maintenance and filing of regulatory documents, maintaining working files, tracking systems, calendars and schedules 
  • Quality control of miscellaneous outbound documents 
  • Providing miscellaneous secretarial support to the Regulatory Affairs staff 

Depending on the experience, the responsibilities may also include:
  • Preparation of regulatory and ethics committee submission dossiers, including import and export licenses 
  • Tracking regulatory project documentation flow and progress reporting 
  • Tracking changes/amendments to legislative acts pertaining to clinical trials in Austria 
  • Contact person for ethics and regulatory authorities, clinical project teams, subcontractors, vendors and clients for all regulatory matters 
  • Review of investigational product release-enabling documents 
  • Developing and implementing corporate quality control tools and techniques pertaining to Regulatory Affairs 
  • Training of company employees in regulatory aspects of clinical trials 
  • Providing miscellaneous support to the Regulatory Affairs staff