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WÖRWAG Pharma located in Böblingen near Stuttgart is a mid-sized, international pharmaceutical company. As a family-owned company we develop and distribute biofactors and generics. We are represented in more than 35 countries with about 1000 employees.


Become a part of our team in our headquarters in Böblingen (near Stuttgart) because we are looking for you as a

 

Regulatory Affairs Specialist (m/f/x) 

 

Tasks & Responsibilities: 

 

  • <span style="font-family:"Arial",sans-serif">Planning of regulatory activities of assigned products worldwide
  • <span style="font-family:"Arial",sans-serif">Compilation of good quality regulatory documents required for registration purposes and submission in the EU markets
  • <span style="font-family:"Arial",sans-serif">Responsible for keeping timelines of planned regulatory submissions (variations, renewals and first marketing authorization applications)
  • <span style="font-family:"Arial",sans-serif">Assistance in defining regulatory strategy for Europe
  • <span style="font-family:"Arial",sans-serif">Responsible for timely submission of response documents to questions of health authorities
  • <span style="font-family:"Arial",sans-serif">Close cooperation and communication with other departments, consultants, CMOs as well as with affiliates
  • <span style="font-family:"Arial",sans-serif">Ensuring timely execution of in-licensing projects

 

Requirements: 

 

  • <span style="font-family:"Arial",sans-serif">Completed studies in pharmacy or a related natural science
  • <span style="font-family:"Arial",sans-serif">At least 3 years of professional experience in Regulatory Affairs preferentially of generic drugs
  • <span style="font-family:"Arial",sans-serif">Extensive knowledge of the technical, legal requirements and practical experience regarding the registration and life cycle management of the generic drugs with focus on the EU market (DCP/MRP/National)
  • <span style="font-family:"Arial",sans-serif">Advances ability to address dossier deficiencies in a manner acceptable to Health Authorities
  • <span style="font-family:"Arial",sans-serif">Advance judgement in determining whether a dossier is sufficiently complete to be accepted for filling by the appropriate Health Authority and identifying potential risks and opportunities  for approval
  • <span style="font-family:"Arial",sans-serif">Accurate, analytical, independent, integrative and responsible working practices, value-oriented thinking and acting
  • <span style="font-family:"Arial",sans-serif">Very good command of English and German

 

What we offer:

 

  • We offer you a challenging and varied scope of tasks in a dynamic team of a successful, mid-sized  pharmaceutical company
  • We offer you exciting projects in an international work environment, with the opportunity to quickly take responsibility and to share your experiences and knowledge
  • In addition to a performance-based salary you receive a comprehensive offer of additional benefits, for example including an occupational pension provision, workplace health promotions, a job ticket as well as diverse training offers

 

We are looking forward to receiving your application!