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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 900 employees.


Become a part of our team because we are looking for you as a

 

Regulatory Affairs Manager EU (m/f) 

Task and Responsibilities:

 

  • Responsibility for the organization and maintenance of registrations in different European countries
  • Ensure the content based and regulatory quality of registration documentation especially related to the quality of administrative documentation (Module 1) for European Registrations, based on the information provided by the responsible internal departments and/or external partners
  • Participation in the organization of complex approval projects in the European context
  • On time handling of regulatory relevant problems (requests, correspondence, deadlines of public authorities).
  • Contact person for RA relevant topics within the company and towards the Health Authorities
  • Compilation, Supervision and adaption of:
    Variations (national or european)
    - New applications (national or european)
    Renewals (national or european)
    Referals
  • Work with dossiers in eCTD format
  • Elaboration and optimization of internal regulatory processes


 

Requirements:

 

  • Completed study of pharmacy or any comparable natural science
  • At least 3 years working experience in Regulatory Affairs, preferably in the pharmaceutical industry
  • Experience with eSubmission (eCTD, xEVMPD) for national procedures as well as for MRP / DCP
  • Worksharing experience and new application in MRP / DCP procedure
  • Good knowledge of legislation requirements (e.g. EU-guidelines) regarding submissions, renewals, variations
  • Good knowledge in technical or content related requirements of a submission dossier
  • Very good computer skills (MS-Office)
  • Very good English skills, knowledge of German or other languages of an advantage
  • Readiness to cooperate with internal departments (purchasing, medical, QA, international business etc.) and external partners
  • Independent, structured and integrative way of working, assertiveness, ability to handle conflicts, ability to work under pressure

 

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 forwar to receiving your application!

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