Regulatory Data Steward

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.

Master data is crucial for regulatory & Pfizer because it ensures the accuracy, consistency, and reliability of data used in regulatory submissions and compliance processes. Accurate master data directly impacts the quality, safety, and efficacy of products, and any inconsistencies can lead to delayed approvals, product recalls, and regulatory penalties. The Regulatory Data Steward is accountable for the creation and maintenance of V-RIM Master Data on behalf of the organization.

The role demands significant experience and understanding of regulatory data, interdependencies within and across Vaults and its implications across the business to ensure product compliance. They support strategy implementation, bridging strategy and execution, and offering crucial insights and feedback at the strategic level.

A percentage of the role will be dedicated to harnessing Veeva data and to advance the digital landscape within Global Regulatory Sciences.

Due to the broad scope, the position provides growth opportunities in Operations, Strategy, and Digital.

JOB RESPONSIBILITIES

- 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, BPO’s, data owners and operational partners, challenging perspectives where necessary based on their domain expertise.
- Ensure data consistency and accuracy across different systems and platforms, enabling connectivity and establishment and implementation of data management best practices inclusive of single authoritative source data.
- Conduct regular QC, data audits, identify data issues, and adhere to data quality standards as defined by data governance (DOVE).
- Lead data remediation projects in alignment within current and emerging global standards.
- Review and Approve Data Changes: Evaluate and approve data change requests, ensuring compliance with data governance policies.
- Serve as a major source of innovative ideas seeking future efficiencies and effectiveness whilst formulating new common optimum process in support of products through the development and commercial Lifecyle of a drug.
- Manage and/or support Data Coordinators, clarifying and providing awareness overviews of changed or new processes.
- Ensure escalations, business process & solution achieves business needs.
- Evolve service based on strategic objectives - efficiency / quality drivers.
- Provides guidance to and/or may lead/co-lead moderately complex projects.
- Applies skills and discipline knowledge to contribute to the achievement of work within Department.
- Has comprehensive knowledge of the principles, concepts and theories of the discipline, and good understanding/knowledge of principles and concepts of other disciplines.
- Able to operate independently in ambiguous situations.
- May review work completed by other colleagues when acting in mentor role.
- Individual contributor or takes a 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 objective.
- 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.

QUALIFICATIONS / SKILLS

- Bachelor’s or Master’s degree in Life Sciences, Regulatory Affairs, Data Management, or related field.
- Strong experience in Regulatory Affairs or Regulatory Operations with Master’s degree, with some experience 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 are intended to 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 (e.g., ISO IDMP, xEVMPD, SPL).
- Experience with master data managemen