RegulatoryAffairsRegionalProjectManager

Job Description **The Position** * The role is a fixed term contractor for 1-4 years * Participate in MSA project workstream. * Regulatory planning globally and alongside other functions within ORD and OMS (eg: supply, EtE planning and PSM) including efficiency and optimization/simplification strategies * Leads supply optimization discussions (stock build/stock depletion/registration deletion/commercialization of validation batches). * Sets up priorities, organizes, oversees and monitors activities, towards division’s and country's objectives achievement in compliance with policies and standards. **** **Responsibilities** * Lead and coordinates E2E regulatory process for supply chain changes as per guidelines for the APJ (inc China) region as well as regulatory requirements from other regions globally * Supports timely and compliant submission management from RA perspective as well as cross functionally. * Support planning and project management including KPIs and risk mitigation. * For assigned products, changes and tasks, stays updated on relevant regional and local regulations and guidelines and to develop and maintain positive relationship with key players in the regulatory environment. Designs and implements regulatory ad-hoc local action plans, as necessary. * Collects relevant public available regulatory information (regulatory intelligence) and keeps relevant persons appropriately informed. * Leads and supports country regulatory affairs into developing supply chain and business continuity strategy and adhere to the cross functional transition plan and provides clear leadership for these. **** Supply chain management: * Planning globally and alongside other functions within ORD and OMS including efficiency and optimization/ simplification strategies * Leads supply optimization discussions. Dashboard and analysis: * Process mapping, KPI and Create dashboard. * Ensures that all internal stakeholders are well informed and following through on schedule adherence