Junior Regulatory Affairs Specialist

at  Zentiva Group as

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

• 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