Job Opportunities in Romania


September 16, 2024

Zentiva Group, a.s.

București

OTHER


Junior Regulatory Affairs 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 welcome
  • Knowledge of the European DRA legislation.
  • Strong communication and organizational skills, presentation skills.
  • Advanced knowledge of English

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