Global Regulatory Affairs Manager

Regulatory Affairs ManagerThe Regulatory Affairs Manager (RAM) is a regulatory specialist with project management capabilities responsible for leading the end-to-end planning, coordination, and execution of assigned deliverables. The RAM contributes to regulatory submission strategy, identifying submission risks and opportunities, whilst leading simple through to more complex regulatory applications and managing procedures through to approval. The RAM provides regulatory expertise and guidance on procedural and documentation requirements to GRET (Global Regulatory Execution Team), GRST (Global Regulatory Strategy Team), and cross-functional teams working flexibly within and across regions to ensure the delivery of business objectives.Accountabilities/Responsibilities:Understanding the regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regions.Providing regulatory input on procedural and documentation requirements as defined by Health Authorities for assigned deliverable(s) including:Submission delivery strategy of all dossiers and all application types per market and/or region.Review of documents (e.g. response documents, study protocols, PSRs, etc.).Coordinate the input, maintenance and revision in the PLANIT project plans for assigned projects, and highlight unforeseen changes in resource demand in a timely manner to Lead RPM and line manager.Contribute to process improvement.