Regulatory Affairs Specialist

at  Zentiva Group as

Your Responsibilities:

• To compile, check and update registration documentation according to legislative requirements
• Coordination: To co-operate with appropriate departments, to set partial tasks and check their realization for the purpose of controlling all the processes of registration proceedings
• Registration procedures Management: communication with internal and external partners, coordination of procedure
• Responsibility for products maintenance
• Legislation/Trends: To monitor legislation as regards a drug regulation as well as developmental trends in the branch for the purpose of implementation of DRA requirements into internal company standards

We require:

• University degree in chemistry/natural science/pharmacy
• Work experience not required, but advantage
• Professional Knowledge and Skills
• Knowledge of the European DRA legislation
• Decision-making skills
• Applicable legal requirements
• Communication and organizational skills

• To compile, check and update registration documentation according to legislative requirements
• Coordination: To co-operate with appropriate departments, to set partial tasks and check their realization for the purpose of controlling all the processes of registration proceedings
• Registration procedures Management: communication with internal and external partners, coordination of procedure
• Responsibility for products maintenance
• Legislation/Trends: To monitor legislation as regards a drug regulation as well as developmental trends in the branch for the purpose of implementation of DRA requirements into internal company standard