Regulatory Data Manager

Vault RIM process and system is highly dependent on accurate & complete metadata at all levels and there is also ​an increasing amount of data that Health Authorities are requiring to be tracked and submitted.​ The Regulatory Data Coordinator is responsible for driving key & critical activities within the Pfizer RIM system in support of enabling the assessment and subsequent management of new or required changes (system events). They will specifically review all events initiated across the product lifecycle, completing system impact assessments, and creating Activities, Regulatory Objectives, Submissions to enable GRS to take the necessary actions. The Coordinator also ensures that Event Details, Change Items & Label Concepts are associated and have the appropriate details as well as creating the Global Content Plan in readiness for content authoring across the enterprise. The Coordinator will work with the CMC Product strategist(s), labeling leads, Clinical & Country Regulatory Strategists through a mix of strategic and operational support, demanding a detailed understanding of regulatory system structures, product licences & master data as well as the end-to-end regulatory change management experience within & across  domains. Job responsibilities: • Manage all RIM events and related records, including event and registration details, ensuring structures and relationships accurately reflect product market registrations, align with master data standards, and remain updated in accordance with health authority decisions. • Interpret health authority communications, drive appropriate system updates, notify stakeholders as needed, and collaborate with GRS stakeholders, CMC strategists, PGS, and cross-functional teams to understand and fulfill data requirements. • Review and approve data change requests, ensuring compliance with data governance standards, policies, and regulatory requirements. • Maintain active dossiers throughout the product lifecycle, ensuring ongoing accuracy, completeness, and alignment with health authority decisions. • Train and support business users on data quality standards, data management practices, and process management best practices. • Identify and implement innovative solutions that improve efficiency and effectiveness while developing and optimizing processes that support products throughout the drug development and commercial lifecycle. • Ensure escalations, business processes, and system solutions effectively meet business requirements and stakeholder needs. • Drive continuous service improvement by aligning processes, solutions, and capabilities with strategic objectives related to efficiency, quality, and operational excellence. Typical Tasks: • Collaborate with business units, IT, and other stakeholders to understand data requirements, support data-related initiatives, lead data review/update meetings, and provide guidance to system users through advanced system knowledge. • Ensure timely notifications are sent to relevant stakeholders following data updates and generate reports on data quality, data requests, and other key metrics. • Review event information to understand the event's purpose and scope, interpret change items, and ensure appropriate event details are updated to support impact assessments and GPC structure creation. • Create event details using the designated wizard, selecting appropriate actions and fields. • Generate impact assessment reports to identify affected registrations. • Create, verify, and validate activities and related records based on impact assessment reports, ensuring data accuracy, completeness, and proper linkage. • Facilitate the delivery and approval of Pfizer electronic and paper regulatory submissions through the coordination and execution of