Regulatory Data Steward & Team Lead (Secondment -… at Pfizer · Groton

WHY PATIENTS NEED YOU

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 Pfizer’s RIM System 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.

WHAT YOU WILL ACHIEVE

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.

HOW YOU WILL ACHIEVE IT

• 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 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.

Senior Manager:

• Leads a team of global data coordinators, working in support of their assigned portfolio/TA to deliver master data management and oversight of event management, license updates and active dossier.
• 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.

Director (inclusive of above):

• Leads a team of global data coordinators, working in support of their assigned portfolio/TA to deliver master data management and oversight of event management, license updates and active dossier.
• Colleague who does not require management oversight of daily work, self-initiates problem solving, fosters a culture of innovation and is able to navigate ambiguous situations impacting RIO, G&IPE, GRS and beyond through to results. Recognizes when escalation is required.
• Demonstrates domain expertise which drives decision making and design in delivering high, meaningful impact on business results.
• Is a Subject Matter expert of the principles, concepts, and theories in the discipline, and has advanced knowledge of principles and concepts in other disciplines across and outside of GRS.
• Demonstrated experience in matrix management where the colleague does not have autonomy.
• Pre-empts internal / external risk to organization and works across boundaries to mitigate.

QUALIFICATIONS

Must-Have

Senior Manager:

• Applicant must have a bachelor's degree with at least 6+ years of experience; OR a master's degree with at least 5+ years of experience; OR a PhD with 1+ years of experience.
• Bachelor’s or Master’s degree in Life Sciences, Regulatory Affairs, Data Management, or related field.
• 6+ years of experience in Regulatory Affairs or Regulatory Operations, 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.
• 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.

Director (inclusive of above):

• Applicant must have a bachelor's degree with at least 8+ years of experience; OR a master's degree with at least 7+ years of experience; OR a PhD with 5+ years of experience, OR a MD with 4+ years of experience.
• Bachelor’s or Master’s degree in Life Sciences, Regulatory Affairs, Data Management, or related field.
• 8+ years of experience in Regulatory Affairs or Regulatory Operations, with at least 3+ years in a data governance, data management, or data quality role.
• 3+ years management & supervisory experience in a regulatory field managing global resources (if taking formal leadership role).

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 global Data Coordinators.
• Project specific resources & vendor staff as required.

OTHER JOB DETAILS

• Last Date to Apply for Job: August 9 , 2026
• Additional Location Information: USA - Any Pfizer Site
• Eligible for Relocation Package – NO
• Secondment 12 months
• If you are currently in a driving position with a fleet vehicle and this secondment does not require driving as an essential function of the position for 12 months or longer, you will be required to turn in your fleet vehicle for the duration of the non-driving secondment. Please refer to the Fleet Policy and Procedures document for more information.
• There will be no change to your current work location.
• Position is considered Flexible, and colleagues are expected to comply with Log In For Your Day (LIFYD) requirements at site location (e.g. about 2.5 days a week in office).

This role is posted in multiple locations. If you are applying for the role in an secondary job posting location where pay transparency regulations apply, your Talent Advisor will share the local pay information with you during the first interview.

Relocation assistance may be available based on business needs and/or eligibility.

Candidates must be authorized to be employed in the U.S. by any employer.

U.S. work visa sponsorship (such as TN, O-1, H-1B, etc.) is not available for this role now or in the future.

Sunshine Act

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

EEO & Employment Eligibility

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States.

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Regulatory Affairs