Job summary We are committed to delivering medicines to the world with greater speed, without compromising on excellence and integrity. Navigating both local and global regulations is crucial, and the dynamic regulatory landscape demands innovative thinking and meticulous attention to detail. Your unwavering dedication and specialized knowledge will play a pivotal role in broadening and hastening patient access to Pfizer's medicines and vaccines. The RIO Execution Hub Sr Associate is responsible for providing regulatory support to the International country and/or cluster Regulatory teams. This role executes the GRS mission by delivering against goals, executing initiatives, implementing new opportunities, and filling gaps related to the production of regulatory International and operational support. Success in this role is measured by the timeliness, quality, compliance, and efficient delivery of critical on-the-job deliverables, bringing efficiencies to the organization. Key Accountabilities include: Ensure timely delivery of local M1 dossier components, Perform Quality review/approval of the Dossier build Table of Contents provided by Hub Submission/Dossier Managers, Can provide support for simple tenders, out-of-stock reporting, Annual Product Quality Review, risk minimization plans, and regulatory information status for launch planning, Provide support for local audit readiness activities, Dear Healthcare Professional Communication (DHPC) responses, and responses to medical info requests as requested, Partner with Grow submission managers and Regional Submission Hubs to meet growth application delivery in line with International Commercial knots prioritisation and OP plans, Partner with Submission Hubs to meet GRS lifecycle prioritisation for CMC and Labelling changes, Author and review of M1 local documents (cover letters, variations, MA applications), and relevant translations, May engage with Labeling Hubs and clusters/countries on Labels and Artwork updates to include local requirements, ensuring alignment with approved text and supporting launch activities, Support clusters/countries with authoring of simple HA query responses e.g., admin related requests, and coordinate with relevant SMEs/functions (e.g., CMC) to address more complex HA queries, based on CRS query response strategy, Provides regulatory support to lower to medium complexity regulatory activities in the assigned country (Initial applications, commercial lifecycle through to product withdrawal, simple tenders, audits, launch planning support) and applies technical experience to impact business results, Provides subject matter expert (SME) input to projects that impact people, technology, and/or processes within RIO Hubs, GI&PE; and GRS, B.S./B.Scs. is in Pharmacy, Life Sciences, Business or Information Technology (desirable); equivalent relevant professional experience will be considered, Advanced to Fluent English language required. Multilingual skills desirable, Proven technical aptitude and ability to quickly learn and use new software, regulations and quality standards, Advanced Microsoft Office Suite skills, Familiarity with pharmaceutical organizational structures, systems, and culture is preferred, An understanding of country/cluster regulatory requirements and trends is preferred, Relevant experience within pharma, in Regulatory, quality and/or compliance fields preferred, Self-initiates problem solving and is able to navigate ambiguous situations impacting RIO through to results. Recognizes when escalation is required, Demonstrates technical expertise which aids submission execution. Descripción del trabajo Lorem ipsum dolor sit amet , consectetur adipiscing elit. Nullam tempor vestibulum ex, eget consequat quam pellentesque vel. Etiam congue sed elit nec elementum. Morbi diam metus, rutrum id eleifend ac, porta in lectus. Sed scelerisque a augue et ornare. Donec lacinia nisi nec odio ultricies imperdiet. Morbi a dolor dignissim, tristique enim et, semper lacus. Morbi laoreet sollicitudin justo eget eleifend. Donec felis augue, accumsan in dapibus a, mattis sed ligula. Vestibulum at aliquet erat. Curabitur rhoncus urna vitae quam suscipit , at pulvinar turpis lacinia. Mauris magna sem, dignissim finibus fermentum ac, placerat at ex. Pellentesque aliquet, lorem pulvinar mollis ornare, orci turpis fermentum urna, non ullamcorper ligula enim a ante. Duis dolor est, consectetur ut sapien lacinia, tempor condimentum purus. Obtén acceso completo Accede a todos los puestos de alto nivel y consigue el trabajo de tus sueños. Inscríbete ahora