Associate II Reg Strategy, GRS Oncology

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About the role

Use Your Power for Purpose At Pfizer, we are committed to bringing medicines to the world faster without compromising on excellence and integrity. Your dedication and expertise are vital in expanding and accelerating patient access to Pfizer medicines and vaccines. Adhering to both local and global regulations is crucial, and the constantly evolving regulatory landscape demands forward-thinking and meticulous attention to detail. Your role will be instrumental in ensuring that our life-saving treatments reach those in need, ultimately contributing to the betterment of global health.   Role Summary In this role, you will collaborate with Global Regulatory Leads and product teams on lifecycle maintenance submissions and regulatory activities. You will represent a specific region (US, EM, or EU) and provide strategic expertise as part of the Global Regulatory Strategic Team, focusing on life cycle maintenance submission activities, CMC Module 1 document preparation, Safety compliance report and operational activities. Key Job responsibilities 1. Regulatory strategy and lifecycle execution ·       Coordinate lifecycle activities, including variations, supplements, amendments, renewals, withdrawals, post-approval commitments and other maintenance submissions for assigned regions ·       Lead and implement regional regulatory strategies in agreement with key stakeholders for assigned projects/products and in line with the commercial goals. ·       Ensure regulatory positions and submission approaches are aligned across relevant global, regional and country stakeholders. 2. CMC submission operations and eAF CMC process ·       Author and QC electronic applications, cover letters, submission packages as requested by Strategist in support of life cycle maintenance of products ·       Perform quality checks of eAF CMC content for completeness, accuracy and alignment with the approved regulatory strategy and source documents. ·       Identify process gaps and contribute to simplification, automation and continuous improvement of eAF and CMC regulatory workflows. 3. Submission preparation and Health Authority support ·       Prepare, coordinate and quality-check submission components such as cover letters, application forms, response documents, commitments, declarations, product information and administrative documents. ·       Support responses to Health Authority questions by coordinating inputs, consolidating comments, checking consistency and ensuring delivery to agreed timelines and quality standards. ·       Collaborate with country and regional colleagues on submission requirements, and implementation activities. 4. Labeling, safety and aggregate-report support ·       Coordinate regulatory activities related to core and local labeling updates, including impact assessment, submission planning, implementation tracking and reconciliation. ·       Support submission and tracking of aggregate reports, risk-management documents and post-authorization safety or efficacy commitments, as applicable. ·       Generate Pearl reports, WWRS reports etc, in support of safety compliance report, Renewals, launches and                        health authority queries on need basis. 5. Cross-functional collaboration and team contribution ·       Build effective working relationships with Global Regulatory Leads, CMC Regulatory, clinical, safety, labeling, quality, supply, commercial, publishing and country regulatory teams. ·       Participate actively in project and regulatory sub-team meetings, clearly communicate decisions and follow through on assigned actions. ·       Provide activity-based support across products based on business priorities and team capacity. ·       Share knowledge, coach colleagues on established processes and contribute to a co

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