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International Open Positions

With 530 years of heritage, more than 3.000 employees, a leading Research and Development Center and two major production sites in Prague and Bucharest, Zentiva strives to be the champion of Generics to support the daily healthcare needs of people living in Europe.The growth of our organization brings new opportunities for our people to fulfil their potential. It also positions us well to attract the best talent and retain our team to secure our success for future generations. Join us!

Registration Specialist

Your responsibilities:

To compile and prepare the registration documentation according to current guidelines with the aim to obtain marketing authorisation, variations approval, renewals, to implement DRA requirements into internal company standards.

To compile, check, update and audit registration documentation according to legislative requirements, to keep documentation to finished products.

  • To cooperate with the relevant departments, to set partial tasks and check their realization for the purpose of controlling all the processes of registration proceedings.
  • To monitor the legislation and the development trends in the branch for the purpose of implementation of DRA requirements into internal company standards.
  • Independent preparation of documentation for complex registration procedures. Evaluation of the course of registration procedures.
  • The active cooperation on the development/licence projects for the purpose of registration documentation preparation based on standard requirements of DRA.

We require:

University degree in chemistry/natural science/pharmacy.

  • Experience in Regulatory Affairs at least 5 years.
  • Knowledge of the European DRA legislation.
  • Strong communication and organizational skills, presentation skills.
  • Advanced knowledge of English

We offer:

  • Challenging career opportunity to work for a successful international company
  • Opportunity to broaden your knowledge and expertise in your field
  • Possibilities for own personal growth and further language development
  • Competitive remuneration and wide portfolio of employee benefits
  • Above-standard social, healthcare and educational program

Contact

Zentiva
Klára Pavlíková