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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