Reg Submission Lead III, SDE - Pipeline

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About the role

Business Introduction At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people’s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success. We’re uniting science, technology, and talent to get ahead of disease together. Find out more: Our approach to R&D Position Summary Submission Delivery Excellence (SDE) is a Regulatory Affairs function which brings together the planning, operation and execution aspects for key regulatory deliverables such as new chemical entities, product expansion dossiers, labeling outputs, license maintenance and lifecycle management dossiers and regulatory information management. This position will reside in the Pipeline group which is accountable for planning, production and submittal of Regulatory dossiers to GSK’s primary markets to support registration of new medicines in line with R&D objectives for marketed products and line extensions of regulatory licenses worldwide.   In this role, the position holder will be responsible for coordinating major and lifecycle regulatory submissions in our market expansion regions, managing and tracking project timelines, communicating with regulatory and operational staff across various functions, maintaining submission workplans and up-to-date knowledge of global regulations and guidelines to support internal stakeholders.  The position holder will work closely with the GRL/Regional Rep (TG)/EU Agent/LOC (or equivalent) and functional teams to coordinate the appropriate content for specific submission packages within the Regulatory Vault system, maintain an accurate and current project plan and drive team members to deliver compliant submission dossiers to accelerated timelines.   The job holder will support R&D projects ensuring submissions are delivered to agreed timeframes and in compliance with GSK process and policy as they apply to the role. The job holder will serve as a mentor and trainer for those team members to ensure they are delivering on their assigned projects and meeting personal and department objectives.  A clear understanding of Regulatory requirements/guidelines & GSK processes/ways of working is required to be able to consult and advise team members within various contributing functions within a Regulatory matrix environment. Responsibilities • Accountable to Project Lead or GRL/ Regional Rep/ EU Agent / C&EP TG /LOC or equivalent with input from Functional teams (CMC/Clinical/nonclinical) for delivery of assigned submissions to agreed timeframes and appropriate content independently and confidently for EU, US and Rest of the World (ROW) market. • Responsible for coordinating the market expansion activities associated submissions for new registrations and line extensions including the initial NDA/MAAs, type 2 variations/supplements, pediatric submissions and responses to HAQs. • Works with staff from other functions and should be capable of working to senior levels in process development functions in provision of advice, interpretation of relevant guidances, researching topics and resolving issues. • Possess in-depth knowledge of GSK processes, ways of working and provide training, consultation and solutions within the team/ department as well as externally outside the department. • Independently and confidently executes agreed dossier strategy related to assigned deliverables with minimal input from

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