REGULATORY AFFAIRS PROJECT MANAGER
#RAY one of the leading contract research organizations in Egypt and the Middle East
is looking for #Regulatory Affairs Project Manager – on behalf of a Multinational company Affairs Project Manager – on behalf of a Multinational company
• Based in Cairo
• BSc of Pharmacy or related field
Min 3 years’ experience in biological registration
• Manage a new application submission corresponding to company plan as well as the agency guidelines for submission.
• Manage review and submission of all the maintenance activities (renewal & variations) based on company plans and the agency guidelines
• Timely implementation of all plans with strict follow up with both internal & external stakeholders for timely achievement of the plan.
• Maintain the products labelling up to date, implementing global and local labelling decisions, through labelling, review and approval
• Updating the internal Sanofi Systems regularly
• Carrying the planned LCM activities and reflecting the approvals on the internal systems
• Following and complying with all the defined internal policies and procedures of working
• Carry out all the required communication and follow up required with local affiliate, region & corporate as appropriate.
• Carrying the planned Activities and reflecting the approvals on the internal system
• Revision and approval of Promotional Materials & any updated packaging material.