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Regulatory Affairs Manager (f/m) Vienna Austria,  

AOP ORPHAN (company)

Posted on : 01 July 2017

Project Description

 As part of our Regulatory Affairs team you will play a key role in Life Cycle Management of existing approvals and submission of new regulatory projects.

Ready for an ambitious job?

  • You are planning and coordinating the compilation of global regulatory submission documents according to country specific requirements
  • Prepare all labelling documents and track timely submission at the authorities
  • You manage change control processes and oversee post-approval activities
  • You are responsible for regulatory data management (DocuBridge)and electronical xEVMPD (IDMP) reporting

Able to align?

  • You enjoy working in a high-performing international environment
  • You provide regulatory know-how to Project Teams involved in the development of new products
  • You are a team player and like to work cross-functionally and with external partners

Looking for an agile environment?

  • You prefer a high degree of independence and responsibility for assigned projects
  • You enjoy to work in a growing international company introducing solutions for rare diseases to new markets
  • You have a pro-active attitude, the ability to develop new concepts and a creative approach to problem-solving

Professional skills

  • University degree in Natural Science/, Pharmacy, Medicine or comparable education
  • 3-5-year Regulatory Affairs experience in the pharmaceutical industry
  • In-depth knowledge of international regulatory requirements
  • Ability to strategically plan and manage multiple projects
  • Attention to detail and ability to prioritize
  • Strong communication skills to liaise with internal and external partners with different cultural background in English and German

The gross monthly salary provided for this function is a minimum of


1160 Vienna, Austria

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