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Associate Director Regulatory Affairs (m/f) - Germany  

MorphoSys (company)

Posted on : 08 March 2017

Project Description

Your Responsibilities:
  • Act as a key member of the Development Core Team and have responsibility for planning and managing all regulatory activities for assigned product candidates 
  • Define global regulatory strategy 
  • Develop the regulatory project goals from the overall product development plan 
  • Compile and submit IND and clinical trial applications (CTAs) to enable timely start of the clinical trials for the assigned product candidates 
  • Organize and drive preparations for meetings and teleconferences with Health Authorities 
  • Responsible for developing the target product labeling in close cooperation with, e.g. clinical and commercial functions 
  • Provide guidance to other functions to assure clinical trial programs are carried out in accordance with applicable regulations and SOPs. 
  • Data from these trials should support product registration 
  • Collect, review and analyse Health Authority guidelines, competitor information and regulatory precedents and provide respective advice to the Core Team 
  • Provide regulatory risk assessment for development projects  

Your Requirements:
  • Pharmacist, preferably with postgraduate degree (e.g. Ph.D.) 
  • Minimum 8-10 years working experience in Regulatory Affairs in a (bio)pharmaceutical company 
  • Sound knowledge of the relevant national and international regulations relating to the development and approval of biopharmaceuticals 
  • Excellent communication skills, verbal and written (English and preferably German) 
  • Ability to organize and carry out diverse activities in a changing environment often under time pressure 
  • Strong analytical skills to be able to interpret regulatory data and support critical decisions 
  • The ability to work within a team framework and a multicultural environment  

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