Regulatory Project and Data Manager

hace 2 semanas


Ciudad de México GSK A tiempo completo

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.Are you passionate about driving impactful regulatory projects and managing data to support global health initiatives? In this role, you will collaborate with cross-functional teams to ensure regulatory deliverables are met efficiently and effectively. You will play a key role in planning, tracking, and managing regulatory data and projects, contributing to GSK’s mission of getting ahead of disease together. This is an opportunity to grow your career, make a meaningful impact, and be part of a team that values innovation, collaboration, and inclusion.This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:- Develop and Maintain Regulatory Plans: Independently build, manage, and update integrated Regulatory Development Plans (RDPs) to reflect the Global Regulatory Strategy, ensuring deliverables, timelines, and resource needs are accurately captured across all development phases.- Manage Regulatory Work Packages: Add, remove, or adjust work packages within the RDP; maintain predecessor/successor logic; and ensure alignment with global strategy, accurately reflecting development stages and dependencies.- Conduct Scenario Planning: Create and analyze alternative planning schedules to support decision-making at both the project and portfolio levels, and clearly communicate the impact of changes on regulatory timelines.- Collaborate Cross-functionally: Partner proactively with functional plan owners (e.g., Medical, Safety, Clinical) and project managers to ensure alignment of regulatory plans within broader project plans and timelines.- Support Governance Processes: Prepare regulatory inputs for key governance meetings, ensuring data is complete, accurate, and actionable for resource and portfolio decision-making.- Forecast Resources and Costs: Build and maintain schedules to support forecasting of regulatory resources (FTE/IPE) and costs (EPE), in collaboration with regulatory project managers and stakeholders.We are seeking professionals with the following required skills and qualifications to help us achieve our goals:- Broad understanding of the pharmaceutical industry, drug development environment, and R&D processes and objectives.- Project management experience, preferably in the pharmaceutical industry or in a regulatory environment.- Ideally possessing knowledge of Regulatory Affairs responsibilities from pre-IND through post-approval- Ability to work well both independently and within a matrix environment to ensure on-time delivery of objectives- Advanced englishPreferred QualificationsIf you have the following characteristics, it would be a plus:- Experience with project management principles and systems (e.g., Planisware), resource management and reporting features (e.g., Spotfire)**Why GSK?****Uniting science, technology and talent to get ahead of disease together.**GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases - to impact health at scale.People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.**Important notice to Employment businesses/ Agencies



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