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Regulatory Associate/Regulatory Lead (DE) - Germany  

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

Project Description

 

RESPONSIBILITIES:
 Supports all aspects of study registration:  
  • Cooperating with Sponsors and study team, including Project Manager, operational and contracting team in the scope of a national and multinational trial registration 
  • Proposing strategy and timelines for initial and subsequent submissions, estimating risks, proposing and implementing management plan for any arising problems 
  • Preparing and/or verifying regulatory documentation for new study application and amendments 
  • Keeping track of submission schedule, deadlines and relevant changes in the projects; ensuring good organization of work to meet established timelines 
  • Maintaining regulatory files and trackers in assigned projects and being involved in development of new regulatory tools 
  • Maintaining good relationships with Sponsors, Competent Authorities and Ethics Committees 
  • Getting informed about any amendments to local laws and European regulations related to study application and any updates for the area of investigational medicinal products and medical devices 
  • Participating in preparation and updates of local and regional Standard Operation Procedures on regulatory processes under the supervision of Regulatory Staff 
  • Sharing regulatory knowledge and experience  




EDUCATION/ QUALIFICATION:  
  • University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g. nursing certification, medical or laboratory technology) 
  • Minimum of two (2) years of experience in submissions of clinical trials 
  • Very good knowledge of GCP, local regulatory requirements, ICH Guidelines, European Directives 
  • Very good understanding of clinical trial registration process in EU/non-EU countries 
  • Ability to work independently and efficiently according to local regulations, SOP, ICH GCP, EU Directives 
  • Good planning, organization and problem solving abilities 
  • Good communication and interpersonal skills, strong intercultural awareness of international requirements 
  • Good analytical and negotiation skills 
  • Computer competency 
  • Fluent in German and English