Regulatory Affairs Manager

The largest international pharmaceutical company has opened a competition for the position of Regulatory Affairs Manager  

Responsibilities:  

• Reviewing registration files and all related documentation of the Company's products and preparing such documentation in line with local regulations; 
• Preparing Application Forms and other documentation for filing and registration of new products;
• Ensuring that all documentation, samples and other items are provided to relevant agencies as needed; 
• Preparation and coordination of the company transition to a new Eurasian procedure for medicines; 
• Ensuring that all marketed products are aligned with compliance, local and corporate regulatory requirements. 

Requirements:  

• University degree: Pharmaceutical / Chemistry / or relevant; 2 year + experience in Regulatory Affairs; 
• Upper-intermediate English; 
• Knowledge of CTD dossier sections content is required; 
• Understands and effectively communicates across challenging business environment; 
• Initiative, strategic thinking and problem-solving approach. 

Benefits:  

• Fixed salary (based on interview results); 
• Provision of VHI; 
• Power and mobile compensation; 
• Annual bonus.