Regulatory, Data Steward (Manager)

Role Summary

Vault RIM process and system is highly dependent on accurate and complete metadata at all levels, with an increasing amount of data that Health Authorities require to be tracked and submitted. Master data is crucial for regulatory and Pfizer because it ensures the accuracy, consistency, and reliability of data used in regulatory submissions and compliance processes. The Regulatory Data Steward is accountable for the creation and maintenance of V-RIM Master Data on behalf of the organization, including identification of Medicinal Products (IDMP) and creation of applications for initial registrations. The role collaborates with Regulatory Strategy, CMC Leads, Clinical, Non-Clinical, RIO and labeling groups, and partners with Data Coordinators and RIDGE/enterprise-wide Data Governance teams. Note: The role is not accountable for governance or maintenance of dictionary values as designed. The role demands significant experience and understanding of regulatory data and interdependencies across Vaults to ensure product compliance, supporting strategy implementation and providing strategic insights. A portion of the role will focus on harnessing Veeva data to advance the digital landscape within Global Regulatory Sciences, with growth opportunities in Operations, Strategy, and Digital.

Responsibilities

• Individual contributor, working within a matrix environment alongside data coordinators
• Provide guidance to and/or may lead/co-lead moderately complex projects
• Apply skills and discipline knowledge to contribute to the achievement of work within the department
• Have comprehensive knowledge of the principles, concepts and theories of the discipline, and good understanding of related disciplines
• Able to operate independently in ambiguous situations
• May review work completed by other colleagues when acting in a mentor role

Qualifications

• Bachelor‚Äôs and 4+ years of experience or Master‚Äôs degree in Life Sciences, Regulatory Affairs, Data Management, or related field and 2+ years of experience with Master‚Äôs
• 4+ years of experience in Regulatory Affairs or Regulatory Operations, with at least 3 years in a data governance, data management, or data quality role
• Robust understanding of biopharmaceutical industry, regulatory and safety processes, external/internal environment
• Strong understanding of global regulatory submission and compliance requirements
• Detailed understanding of regulatory system structures and how they enable regulatory business needs and support compliance (e.g., Veeva RIM, Liquent, Lorenz)
• Detailed understanding of regulatory SME processes and needs across the lifecycle (e.g., centralized registration procedures, IDMP, CMC, Artwork/Labeling)
• Strong understanding of data governance principles and best practices (certification in data management or data governance such as ISO IDMP, xEVMPD, SPL)
• Experience with master data management and data quality improvement; aptitude for leveraging data to drive efficiency and innovation
• Technical expertise in strategic business planning and operations
• Strong communications skills to convey complex information to diverse audiences
• Global, cross-functional business perspective with strong organizational management and ability to handle multiple demands
• Proven ability to influence and lead cross-functional teams without direct authority
• Ability to deal with ambiguity, show creativity, and adapt in real-time
• Fluent in English