Regulatory, Data Steward

1 week ago


New York, United States Pfizer Full time

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 coordinatorsProvides guidance to and/or may lead/co-lead moderately complex projectsApplies skills and discipline knowledge to contribute to the achievement of work within DepartmentHas comprehensive knowledge of the principles, concepts and theories of the discipline, and good understanding/knowledge of principles and concepts of other disciplinesAble to operate independently in ambiguous situationsMay review work completed by other colleagues when acting in mentor roleQUALIFICATIONS/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's4+ 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 environmentStrong 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/LabelingStrong 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 operationsCommunications Skills: Ability to communicate complex information and analyses, and difficult messages, to a variety of audiences in both verbal and written formatBusiness 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 mannerProven ability to influence and lead cross-functional teams without direct authority.Deals with Ambiguity; Creativity; Ability to Adapt in Real-TimeFluent in EnglishAdditional Job Details:Last date to apply: December 12, 2025The annual base salary for this position ranges from $90,900.00 to $151,500.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 12.5% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.Relocation assistance may be available based on business needs and/or eligibility.Sunshine ActPfizer 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 EligibilityPfizer 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. Pfizer endeavors to makewww.pfizer.com/careersaccessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing, please email. This is to be used solely for accommodation requests with respect to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned.Regulatory Affairs



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