Regulatory Project Lead - Senior

Nombre del sítio: Belgium-Wavre, GSK House, Italy - Siena Fecha de publicación: Dec 7 2022 The Regulatory Project Lead - Senior works closely with the GRL/ Regional Rep/EU Agent (TG), Functional teams and Local Operating Company regulatory contacts to confirm requirements, deliverables and agree timelines and plan/implement delivery strategy for initial MAA/NDA Submission to markets globally in which GSK does business. The Regulatory Project Lead - Senior will ensure that dossiers are prepared in compliance with Regulatory Authority regulations and guidelines and in line with GSK SOPs and working practices. They will also plan and ensure delivery of life cycle activities for products registered in EU (for example variations, periodic benefit risk evaluation reports (PBRER), paediatric investigation plan) and appropriate content for a range of submissions supporting R&D projects is developed and delivered to agreed timeframes and in compliance with GSK process and policy as they apply to the role. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following: Primary contact for Global Regulatory Lead/ Regional rep (TG) for delivery of submissions or strategy components for one or more complex products; planning own and submission team activities to ensure delivery to agreed timeframes and appropriate content Responsible for the development and implementation of the submission strategy for new files, line extensions & new indications in non-major markets Ensures quality of both own and submission teamwork and compliance with regulatory guidelines and process as they apply to the role. Responsible for the implementation of the submission strategy for New files, line extensions & new indications in major markets Accountable to GRL/ Regional Rep (EU Agent)/ C&EP lead for delivery of MAA and Lifecycle maintenance submissions for a complex assigned product in development or marketed product for European Market. Through collaboration with contributing functional lines within and outside of GRA, including LOC, creates and maintains a detailed Submission Plan that captures, key activities and timelines associated with delivery of that content and credible dispatch dates Participates and/or leads submission planning discussions, ensuring team is aware of upcoming deliverables, aligned on roles and responsibilities, understands the interdependencies between submission activities andcomponents, and that any issues, risks, or impact due to changes in strategy and/or timelines are assessed quickly throughout the submission process. Possess in depth knowledge of GSK processes, ways of working andcurrent EU and ROWmarket guidelines and provides support to submission Co-ordinator in resolving issues and bottlenecks to ensure a smooth execution of submission strategy. Monitoring and tracking if the submissions are on schedule and as per plan. Works with staff from other functions and should be able to work with senior leaders in development functions in provision of advice, interpretation of relevant guidances, researching topics, integrating Rx/Vx ways of working and resolving issues. Undertakes Regulatory Matrix Team (RMT) secretariat role. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: More than 7 years of Global/EU/ROW Regulatory submission experience - Knowledge of regulatory agency guidelines Broad understanding of the pharmaceutical industry, drug development environment, and R&D processes and objectives. Excellent project management, leadership & organisational skills, attention to detail and commitment to deliver high quality output, even under pressures sometimes demanded by regulatory deadlines and managing multiple submissions simultaneously Excellent written and verbal communication skills and ability to present information in a clear and concise manner Ability to interpret and advise on guidelines and requirements on a global basis, reflecting recent GSK experience Ability to effectively interact with line and middle management, staff and external contacts on a functional and strategic level in a matrix environment. Ability to lead in a matrix environment and ensure delivery of objectives across cross-functional teams. Ability to build effective working relationships/ Stakeholder management and work in a global matrix environment effectively Expert persuasive skills. Ability to gain consensus on a way forward in an environment where there may be more than one way of achieving a successful outcome. Proven ability to think flexibly in order to meet constantly shifting priorities and timelines. Preferred Qualifications: If you have the following characteristics, it would be a plus: Service orientation, customer-focused English language skills Ability for overseeing and prioritizing multiple activities across one or more sites for multiple customers Project management skills IT skills Knowledge of worldwide regulatory requirements Why GSK? 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. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. 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.
VaccinesRD *Li-GSK Si tiene una discapacidad y necesita asistencia durante el curso del proceso de selección, tendrá la oportunidad de hacernos saber qué asistencia específica necesita para hacer los arreglos adecuados. Nuestro objetivo es ser una de las empresas de atención médica más innovadoras, de mejor desempeño y más confiables del mundo. Creemos que todos aportamos algo único a GSK y cuando combinamos nuestros conocimientos, experiencias y estilos, el impacto es increíble. Únase a nuestra aventura en GSK donde se inspirará para hacer el mejor trabajo para nuestros pacientes y clientes. Un lugar donde puede ser usted mismo, sentirse bien y seguir creciendo. Aviso importante a las empresas o agencias de empleo GSK no acepta recomendaciones de empresas de empleo o agencias de empleo con respecto a las vacantes publicadas en este sitio. Todas las empresas o agencias de empleo están obligadas a ponerse en contacto con el Departamento de Contrataciones Comerciales y Generales o el Departamento de Recursos Humanos de GSK para obtener autorización previa por escrito antes de recomendar a cualquier candidato a GSK. La obtención de autorización previa por escrito es una condición precedente a cualquier acuerdo (verbal o escrito) entre la empresa o agencia de empleo y GSK. En ausencia de dicha autorización por escrito, se considerará que las acciones que emprenda la empresa o agencia de empleo se han realizado sin el consentimiento o el acuerdo contractual de GSK. Por lo tanto, GSK no será responsable de ninguna tarifa derivada de tales acciones o cualquier tarifa que surja de cualquier recomendación por parte de las empresas o agencias de empleo con respecto a las vacantes publicadas en este sitio.