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
