Sr. Manager, Regulatory Asset Oversight Job in Gsk Plc

• 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,
• 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.
• Leverage expertise to assist RMTs and GRLs with submission delivery strategies that align with R&D objectives, e.g. Hyper-Acceleration, Acceleration in regions.
• 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.
• 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.
• 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.
• 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.
• 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. Maintains meaningful metrics and KPIs to assess individual and team performance which are aligned across the Regulatory Asset Oversight function.
• Support the GRL in the preparation of governance reviews leveraging data from RIM systems and ensuring accuracy, completeness, and fit for purpose.
• 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.

• Bachelor s Degree
• Extensive knowledge of drug development and manufacturing and supply processes.
• Broad and deep knowledge of worldwide regulatory requirements.
• Successfully managed multiple projects

• Degree in Chemistry, pharmacy or closely related science
• Demonstrated professional growth in global regulatory affairs including communication of evolving/emerging trends and policies.
• Broad knowledge base across regulatory functions.
• Experience in influencing and negotiating with GSK personnel as well as external partners in a variety of settings.
• Line management experience

• Agile and distributed decision-making using evidence and applying judgement to balance pace, rigor and risk.
• Managing individual and team performance.
• Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
• Implementing change initiatives and leading change. Sustaining energy and well-being, building resilience in teams.
• Continuously looking for opportunities to learn, build skills and share learning both internally and externally.
• Developing people and building a talent pipeline.
• Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation.
• Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally.
• Budgeting and forecasting, commercial and financial acumen.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a special purpose to unite science, technology and talent to get ahead of disease together so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

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