The roleThis role will support one or more oncology products from a European regulatory perspective. As a member of the Global Regulatory Team (GRT), you will define the regulatory strategy and support the desired labelling by developing and executing regional regulatory strategies and managing effective agency interactions.Responsibilities*Plans and manages regulatory submissions (e.g. clinical trial and marketing applications) for products within the client's portfolio in compliance with global filing plans and local regulatory requirements.*Implements product-related regulatory strategies, Regulatory Affairs processes and activity planning in accordance with national legislation and regulatory requirements.*Leads the development of regional regulatory documents and meetings in accordance with GRT strategy.*Provides regulatory direction on regional regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, conditional/accelerated approvals, compassionate use and paediatric plan).