Regulatory, Data Steward & Team Lead

Role Summary

Regulatory, Data Steward & Team Lead (Sr. Manager) responsible for leading the creation and maintenance of V-RIM Master Data, including identification of Medicinal Products (IDMP) and initial registrations. Partners with Regulatory Strategy, CMC Leads, Clinical, Non-Clinical, RIO and labeling groups to generate and maintain data, while working with Data Coordinators and enterprise Data Governance teams. Leads data coordination efforts within Vaults to ensure data accuracy, completeness, and regulatory compliance, with a portion of time focused on leveraging Veeva data to advance Global Regulatory Sciences and shaping growth across Operations, Strategy, and Digital.

Responsibilities

• Formal leadership role of data coordinators alongside their data steward accountabilities
• Develops ideas and leads/co-leads complex projects across Sub Business Unit/Sub Operating Unit
• Develops and manages plans to achieve objectives
• Applies skills and domain expertise to contribute to the achievement of work within Sub Business Unit/Sub Operating Unit
• Has advanced knowledge of the principles, concepts and theories in the discipline, and comprehensive knowledge of principles and concepts in other disciplines
• Makes decisions that require developing innovative options to resolve complex problems
• Makes decisions within general business line or functional guide
• Leads operational team(s) within and across Work Teams and Departments
• Generate & Maintain Regulatory & Enterprise Master Data: Accountable for leading the accurate definition & recording of master data in alignment with data standards, driving discussions with strategy partners, BPOs, data owners and operational partners, challenging perspectives where necessary based on their domain expertise
• Execute & oversee application/registration creation: Determining when to create new vs. use existing objects, system structure of objects needed to enable accurate product representation and management in collaboration with GRS lines
• Ensure accuracy, completeness, and consistency of data within the Veeva Vault RIM system by verifying/updating data, handling approved change requests, maintaining data quality, and resolving regulatory information issues
• Oversee portfolio in partnership with Data Coordinators as part of a matrix, product-aligned model; establish subject matter expertise in product data, global licenses & registrations, and active/historical changes
• Data model, hierarchy and standards subject matter expert; maintain knowledge of data relationships & dependencies within regulatory and enterprise vaults
• Ensure data consistency and accuracy across systems; implement data management best practices including a single authoritative source
• Conduct regular QC and data audits; identify data issues and adhere to data governance standards (DOVE)
• Lead data remediation projects aligned with current and emerging global standards
• Review and approve data changes; ensure compliance with data governance policies
• Generate innovative ideas for future efficiencies and optimize processes in support of drug development and lifecycle management
• Manage and/or support Data Coordinators; clarify and provide awareness of changed or new processes
• Ensure escalations and solutions meet business needs; evolve service based on strategic objectives

Qualifications

• Bachelor‚Äôs and 6+ years of experience or Master‚Äôs degree in Life Sciences, Regulatory Affairs, Data Management, or related field
• 5+ years of experience in Regulatory Affairs or Regulatory Operations with Master‚Äôs degree, with at least 3 years in a data governance, data management, or data quality role
• Emerging people leader with proven experience managing colleagues and/or contractors within a matrix environment
• Strong understanding of global regulatory submission and compliance requirements
• Detailed understanding of regulatory system structures and how they enable regulatory business needs and compliance (e.g., Veeva RIM, Liquent, Lorenz)
• Detailed understanding of regulatory SME processes across the lifecycle (centralized registration procedures, IDMP, CMC, Artwork/Labeling)
• Strong understanding of data governance principles and best practices; certification in data management or data governance (e.g., ISO IDMP, xEVMPD, SPL)
• Experience with master data management and data quality improvement; ability to leverage data to drive efficiency and innovation
• Technical expertise: knowledge of strategic business planning and operations
• Strong communications skills; ability to convey complex information to diverse audiences
• Global, cross-functional perspective with strong organizational, time-management, and discretion
• Proven ability to influence and lead cross-functional teams without direct authority
• Ability to deal with ambiguity, creativity, and real-time adaptation
• Fluent in English