Regulatory Affairs Sr. Manager/Associate Director

Essential Functions
• May act as a Project Manager for a large stand-alone programme, involving several regulatory or technical deliverables and/or region, and/or operation; Undertakes risk analysis, management and contingency plans, as appropriate;
• Provides strategic regulatory and/or technical consultancy on a variety of projects, internally and externally, using innovative solutions where appropriate;
• May manage meetings with Regulatory Agencies;
• May write and/or review a complete single service regulatory proposal and defend costs and timelines to clients;
• Provides mentorship to junior colleagues and advise others on many regulatory document types;
• May plan and deliver workshops or presentations on Regulatory Affairs topics for conferences or publications;
• May be assigned as Reviewer and/or Approver for Regulatory standard operating porcedures or cross-functional standard operating porcedures owned by other operations;
• May sup...