Sr. Manager/Associate Director, Regulatory Asset Oversight

<p></p><p></p><p>The <span> Sr. Manager/Associate Director, Regulatory Asset Oversight </span><b> </b>will partner with the GRL and Regulatory Matrix Teams (RMT) and Early/Medicine Development Teams to provide over-arching project management support to active Rx and Vx projects across the lifecycle of the asset. Create and manage integrated regulatory plans, for purposes of operationalizing the Global Regulatory Strategy (GRS), and ensure team is on track to deliver per the Regulatory strategy. Facilitate the running of the RMT and acting as conduit for the GRL to the wider regulatory organisation and through their extended network engage with key partners outside of regulatory. Will be responsible for ensuring a consistent approach to Regulatory Asset oversight activities within and across project teams which best serve R&amp;D Pipeline and key Established Products goals and ultimately the Patient. Responsible for promoting an agile and forward-looking culture which utilizes innovative technologies and techniques to develop comprehensive workplans which align with acceleration, efficiency, and compliance objectives. Collaborates and networks across the R&amp;D matrix to ensure that project management and submission oversight activities are agreed and aligned to efficiently support R&amp;D portfolio aspirations. Coordinates with Submission Delivery Excellence colleagues on the operational execution of the strategy. This role requires leadership within and across enterprise matrix teams including GRA (both central and at the Local Operating Company level), GRO, and contributing departments (e.g. Clinical Operations, Data Management, Stats and Programming) as needed to facilitate submission delivery expectations.</p><p></p><p><b>The job holder may be responsible for managing other Regulatory Asset Oversight Managers.</b></p><p></p><p><span><b>This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following…</b></span></p><ul><li><p>In close collaboration with the GRL and RMT, develop and maintain a holistic view of the global regulatory integrated plan at the asset level for operationalizing the Global Regulatory Strategy and supporting the GRL in ensuring appropriate resource is engaged to deliver to the plan,</p></li><li><p>Drive the execution of the agreed plans to ensure team is on-track to deliver per the Global Regulatory Strategy (GRS), performing scenario planning, impact analyses, critical path analyses and facilitate risk mitigation in response to any issues/risks that arise.</p></li><li><p>Leverage expertise to assist RMTs and GRLs with submission delivery strategies that align with R&amp;D objectives, e.g. Hyper-Acceleration, Acceleration in regions.</p></li><li><p>Implement a structured approach with assigned RMTs to ensure that the submission delivery strategy is aligned with the Global Submission Strategy (GSS) throughout the late-stage Development lifecycle.</p></li><li><p>Proactively partner as a Single Point of Contact with RMT, Submission Coordination, and Publishing colleagues to identify and remove barriers that will prevent a successful outcome on defined filing strategies.</p></li><li><p>Drive the RMT Meeting and other Cross-Functional, Regulatory-Owned Engagements for success ensuring logistics, agenda topics and meeting materials are available and organized for the use of the team.</p></li><li><p>Proactively identifies upcoming activities or milestones which might impact regulatory deliverables and escalates of issues and blockers to the Director, Regulatory Asset Oversight, and leadership.</p></li><li><p>Promote and drive the use of integrated Regulatory technologies to provide real-time, accurate submission status information (visuals and reports) for RMTs to highlight compliance from central dispatches through to registrations across markets.</p></li><li><p>Maintains meaningful metrics and KPIs to assess individual and team performance which are aligned across the Regulatory Asset Oversight function.</p></li><li><p>Support the GRL in the preparation of governance reviews leveraging data from RIM systems and ensuring accuracy, completeness, and fit for purpose.</p></li><li><p>Facilitate discussions with LOCs and RMTs as needed to ensure aligned submission delivery strategy and efficient lifecycle filing strategies from lead markets through to regional expansion. Job Description</p></li><li><p>Serve as SME inputting to WoWs in conjunction with Stakeholders with a focus on continuous improvement, identification and implementation of automation opportunities, and compliance with Regulatory authority requirements.</p></li><li><p>Maintains a network amongst GRA and R&amp;D colleagues for awareness of best practices and identification of future opportunities.</p></li></ul><p></p><p></p><p><span><span><b>Why you?</b></span></span><span><span> </span></span></p><p><b>Qualifications: </b></p><p>We are looking for