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.

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.
• Execute & oversee application/registration creation: Determining when to create new v. use existing objects, system structure of objects needed to enable both accurate representation of the product and management of the product in the system in collaboration with GRS lines .
• Responsible for ensuring the accuracy, completeness, and consistency of data within the Veeva Vault RIM system by verifying and updating data, executing approved change requests, maintaining data quality, and resolving issues related to regulatory information, such as applications, submissions, products, and commitments. This role involves data research, communication with internal and external stakeholders, and adherence to data governance policies to support global regulatory processes.
• Oversee the portfolio in partnership with Data Coordinators as part of a matrix, product aligned model. Establish subject matter expertise in product data, global license & registrations and active & historical changes.
• Data model, hierarchy and standards subject matter expert, maintaining a detailed working knowledge of data relationships & dependencies within regulatory and enterprise-wide vaults.
• Ensure data consistency and accuracy across different systems and platforms, enabling connectivity and establishment and implementation of data management best practices inclusive of single authroatativr 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
• 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 or Master's degree in Life Sciences, Regulatory Affairs, Data Management, or related field.
• Some experience in Regulatory Affairs or Regulatory Operations with Master's Degree 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 to Adapt in Real-Time.
• Fluent in English.

ORGANIZATIONAL RELATIONSHIPS

• Regulatory Strategy, CMC leads, Clinical, Non-Clinical, Data Coordinators, RIO, Digital.
• Will work in a highly matrixed environment and in close collaboration with Operations and Strategy.

RESOURCES MANAGED

• Lead Data Coordinators in a matrix or formal reporting relationship.
• Project specific resources & vendor staff.

Work Location Assignment: Hybrid (some office presence is required)

Purpose

Breakthroughs that change patients' lives
... At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.

Digital Transformation Strategy

One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience.

Flexibility

We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self. Let's start the conversation

Equal Employment Opportunity

We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms – allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.

DisAbility Confident

We are proud to be a Disability Confident Employer and we encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments necessary to support your application and future career. Our mission is unleashing the power of our people, especially those with unique superpowers. Your journey with Pfizer starts here

Regulatory Affairs