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Registration Manager (m/f)

Registration Manager (m/f)
Regulatory Affairs, Sandoz Development Center, Sandoz GmbH Kundl

Area of Responsibility

  • Organisation and preparation of marketing authorisation documentation for new registrations, renewals, and variations according to the applicable guidelines, authority regulations and legal requirements
  • Carries out regulatory activities independently and co-operates proactively with other departments
  • Competent contact person, advising the Development Department, TechOps, QA and other internal and external stakeholders with regard to regulatory issues
  • Coordination of registration strategies with the country-specific administrative marketing authorisation departments (RCCs)
  • Regulatory evaluation of Change Requests
  • Generation of regulatory guidance documents, review and approval of guidance documents, protocols, reports and SOPs where appropriate
  • Representative of regulatory in the corresponding project team.


  • Education: University degree (preferably PhD) in natural science such as pharmacy, chemistry, microbiology etc.
  • Languages: fluent in German and English
  • Experience: Minimum of 2 years of experience in the pharmaceutical industry
Our salary packages are competitive and take individual qualifications and experience into consideration. Moreover we offer attractive fringe benefits (e.g. profit sharing for all employees, modern company pension, childcare facility, training possibilities and global career opportunities). In accordance with the Austrian collective labour agreement, we advise you that the minimum gross annual salary for this role is 48,020.56 euros.
Contact: Cornelia Walch, Staffing Manager
Job-ID: 187038BR
Sandoz is an equal opportunity employer
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Über Sandoz GmbH

Sandoz ist eines der größten Pharmaunternehmen Österreichs mit über 4000 Mitarbeitern. Als Teil der weltweiten Novartis Gruppe entwickeln, fertigen und vermarkten wir patentfreie Arzneimittel vor allem Antibiotika, injizierbare Krebsmedikamente und innovative Biosimilars. Mit unseren Arzneimitteln verbessern wir die Lebensqualität von Patienten in aller Welt....

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