Regulatory Specialist Country Labelling
hace 7 días
**Site Name**: Mexico City Torre Mitikah**Posted Date**: Jun The Job Holder provides support to Global Regulatory Affairs Labelling staff, Regulatory Matrix Teams and Local Operating Companies to ensure the timely update, management and communication of quality regional/country Product Information (PI)/labelling and supporting documentation. The Job Holder ensures effective coordination, communication and maintenance of regional/country labelling documents and data in regulatory systems in accordance with defined standards and processes.**Responsibilities**- Prepare and compile regional/country-specific labelling documents and supporting materials in compliance with regulatory authority requirements and internal standards.- Provide regulatory labelling support to global and local Global Regulatory Affairs teams, including authoring, reviewing, and coordinating labelling submissions.- Perform quality and consistency checks of labelling content and manage documentation in regulatory systems.- Advise global and local stakeholders on labelling requirements, processes, and standards, including participation in Regulatory Matrix Teams.- Communicate effectively with cross-functional teams, and where applicable, with regulatory agencies and third parties.**Basic Qualifications**- Bachelor’s degree in Science or Life Sciences or similar.- Work experience within Regulatory Affairs in the Drug development environment.- Excellent written and verbal English language communication skills and ability to present information to diverse colleagues in global locations in a clear and concise manner.- An understanding of labelling (e.g. through direct or indirect exposure to the management of labelling documents/submissions/data).Temporary Contract until December 31st.**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.**Important notice to Employment businesses/ Agencies
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