{"id":2731255,"url":"https://alion.io/job/pfizer-regulatory-data-manager","title":"Regulatory Data Manager","company":{"id":3480,"name":"Pfizer","domain":"pfizer.com","url":"https://alion.io/company/pfizer","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":null},"role":"Administrative","role_family":"Administrative","seniority":"lead","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Escazú, Costa Rica","Mexico City, Mexico","Colombia"],"countries":["CR","MX"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":30000,"max_usd":78000,"period":"year","method":"global_role_cell_scaled_by_country","sample_n":270},"experience_years_min":4,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Master Data Management","optional":false}],"status":"live","first_seen_at":"2026-10-16T18:02:30Z","employer_posted_date":"2026-10-16","last_verified_at":"2026-10-16T18:02:30Z","board_verified":true,"closed_at":null,"days_open":0,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":0},"description":"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.\nThe 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).\nThey 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.\nThe 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.\n\nJob responsibilities:\nManage 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.\nInterpret 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.\nReview and approve data change requests, ensuring compliance with data governance standards, policies, and regulatory requirements.\nMaintain active dossiers throughout the product lifecycle, ensuring ongoing accuracy, completeness, and alignment with health authority decisions.\nTrain and support business users on data quality standards, data management practices, and process management best practices.\nIdentify and implement innovative solutions that improve efficiency and effectiveness while developing and optimizing processes that support products throughout the drug development and commercial lifecycle.\nEnsure escalations, business processes, and system solutions effectively meet business requirements and stakeholder needs.\nDrive continuous service improvement by aligning processes, solutions, and capabilities with strategic objectives related to efficiency, quality, and operational excellence.\nTypical Tasks:\nCollaborate 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.\nEnsure timely notifications are sent to relevant stakeholders following data updates and generate reports on data quality, data requests, and other key metrics.\nReview 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.\nCreate event details using the designated wizard, selecting appropriate actions and fields.\nGenerate impact assessment reports to identify affected registrations.\nCreate, verify, and validate activities and related records based on impact assessment reports, ensuring data accuracy, completeness, and proper linkage.\nFacilitate the delivery and approval of Pfizer electronic and paper regulatory submissions through the coordination and execution of CMC components in accordance with submission and national market requirements.\nManage submission status and deliverables, identify risks, and partner with regulatory strategists and stakeholders to mitigate risks while maintaining accurate metadata in regulatory workflow and document management systems.\nLead or co-lead moderately complex projects and provide guidance to project teams.\nManage priorities, meet objectives, and forecast and plan resource requirements, including people, financial, and technology resources, across projects.\nApply discipline expertise and technical skills to support departmental objectives and deliver high-quality work.\nAnalyze moderately complex issues and develop effective solutions to address business challenges.\nMake decisions in non-standard situations while adhering to established policies and procedures.\nFacilitate team discussions, build consensus, and drive progress toward work team goals through informal leadership.\nServe as a subject matter expert in regulatory processes, systems, and procedures while collaborating across matrixed teams and stakeholders.\nRepresent the RIO function and contribute to RIO, GI&PE, and GRS continuous improvement initiatives and projects.\n\nQualifications and skills:\nBachelor’s or Master’s degree in Life Sciences, Regulatory Affairs, Data Management, or related field\n4+ years of experience in Regulatory Affairs or Regulatory Operations, with at least 3 years in a data governance, data management, or data quality role.\nProduct lead/support experience, including management of product/registration information in systems\nE2E global regulatory change management experience, including change initiation, performing impact assessments, submission to HA and management of HA decisions/queries/interactions/commitments\nDetailed understanding of regulatory system structures and how they are intended to enable regulatory business needs and support compliance\nDetailed understanding of regulatory SME processes and needs across the lifecycle, e.g. centralized registration procedures, IDMP, CMC, Artwork/Labeling\nDetailed understanding of GRS roles/responsibilities related to dossier maintenance and submissions\nStrong understanding of data governance principles and best practices.\nExperience with master data management and data quality improvement.\nProven technical aptitude and ability to quickly learn and use new software, regulations and quality standards.\nStrong communication and collaboration skills.\nAttention to detail and commitment to data accuracy and integrity.\nAvailable to apply until: October 29th EOD.\nEEO (Equal Employment Opportunity) & Employment Eligibility\nPfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, or disability.\nTo learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers.\nRegulatory Affairs","description_format":"text","description_chars":6859,"description_truncated":false,"requirements":{"experience_years_min":4,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Prescription Drugs","Oncology Therapeutics","Infectious Disease Therapeutics"],"lifecycle":[{"event":"open","at":"2026-10-16T18:02:30Z"}],"visa":[],"liveness":{"score":86,"band":"hot","label":"Hiring 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