Regional Regulatory Affairs Strategist

Position Summary

The main purpose of the Regulatory Affairs Strategist is being responsible for registration dossier compilation, getting factories, markets and other stakeholders agree to a registration master plan and ensure all stakeholders commit to that plan. This role will be part of Global Regulatory Team - Worldwide regulatory Operations and Compliance ‘WROC’. This position will manage regulatory activities for multiple markets.     

A day in the life of...

• Develop & Implement Registration strategy following stakeholder agreement for individual market requests or global projects    
• Provide clear Regulatory direction and assessment to factories and markets in relation to requirements and factory change initiatives or queries.  
• Compile all registration related documents from factory and other sources as applicable and delivered to market on time   
• Perform final review of the documents received from factory and all other received documentations as per market requirements prior to dispatch to market thus ensuring Right First-Time delivery 
• Coordinate and provide assessment to market responses for factory information requests and change management assessment
• Support Regulatory and Scientific Affairs (RSA) Managers in Regulatory Assessment functions, absence cover and Importation challenges such as Inter Market Supply 
• Active member of RSA team, contributing and leading as required Operational Master Plans ‘OMP’ & Objective setting