Regulatory, Data Steward (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.​

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.

They are specifically responsible & accountable for the creation & maintenance of core/master data inclusive of dentification of Medicinal Products (IDMP) and creation of applications, e.g. for initial registrations. They work in close collaboration with Regulatory Strategy, CMC Leads, Clinical, Non-Clinical, RIO and labelling groups to generate and maintain data and form a partnership with Data Coordinators and RIDGE/enterprise-wide Data Governance teams. Note: Role is not accountable for governance or maintenance of dictionary values as designed.

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.

Manager:

• Individual contributor, working within a matrix environment alongside data coordinators

• 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

QUALIFICATIONS/SKILLS:

• Bachelor’s and 4+ years of experience or Master’s degree in Life Sciences, Regulatory Affairs, Data Management, or related field and 2+ years of experience with Master's

• 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 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 management and data quality improvement. Aptitude for how data can be leveraged to drive efficiency and innovation.

• Technical Expertise: Demonstrated knowledge of / experience with strategic business planning and operations

• Communications Skills: Ability to communicate complex information and analyses, and difficult messages, to a variety of audiences in both verbal and written format

• Business Perspective: Cross functional, Global perspective within the context of business needs and impact.  Must have demonstrated business acumen; strong organizational management skills, the ability to handle multiple demands simultaneously; the ability to respond to tight timelines; as well as the capability to interact with all levels of the organization in a professional and discrete manner

• Proven ability to influence and lead cross-functional teams without direct authority.

• Deals with Ambiguity; Creativity; Ability