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Pfizer

Regulatory Data Excellence & Integrity Lead

Posted 2 Days Ago
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Hybrid
New York City, NY, USA
124K-207K Annually
Senior level
Hybrid
New York City, NY, USA
124K-207K Annually
Senior level
Leads global regulatory data management, integrity, quality, governance, and compliance activities across Pfizer systems. Oversees regulatory milestones, license-status conformance, audits, KPIs, process improvements, and strategic transformation initiatives. Partners with business process owners and digital stakeholders to improve data quality and operational efficiency, while influencing cross-functional decisions and safeguarding patient safety. Manages project resources, contractors, and staff development in a global matrix environment.
The summary above was generated by AI
Reports to Head, Regulatory Data Vanguard (RDV) and accountable for the oversight & execution of global data management activities spanning multiple regions, products etc. in support of new and remediation activities. Also accountable for the overall integrity and quality of Pfizer Global regulatory data through the oversight of data quality, completeness and timeliness, working in close partnership with the relevant BPO's to inform procedural and process updates.
Accountable for measuring, experimenting and driving GRS towards data excellence through innovation and improvement, utilizing existing and new capabilities such as AI, data science, automations and reports in support of optimizing data quality and efficiencies for GRS.
This role will also be responsible for completing, overseeing, or supporting strategic initiatives identified by GRS in support of progressing/evolving GRS Data management. Typical projects can include working on business transformation, implementing change management, building new capabilities, increasing business efficiency efforts, re-designing complex processes or working on program management efforts for global/regional projects.
Finally, this role is responsible for liaising and influencing partner lines in the interest of safeguarding patient safety through high quality data management across Pfizer systems.
JOB RESPONSIBILITIES
Key Accountabilities:
  • Accountable for the oversight of global data management activities and stewardship of Regulatory Milestones and license status conformance within regulatory systems
  • Champion innovation and takes appropriate risks to challenge the status quo, resulting in enhanced processes that impact the business directions of cross functional teams and Business Units
  • Influences senior management decisions that have an impact on business direction to support global regulatory data strategies across all global business units and markets
  • Lead the evolution of data management & quality oversight in partnership with business and digital partners
  • Ensures overall data integrity through audit and verification checks, performing quality control of timeliness, accuracy and completeness of data.
  • Develop key performance indicators in order to ensure accurate and timely execution of improvement initiatives and guarantee increased compliance in relevant processes.
  • Liaise with business process owners, ensuring interpretations of compliance requirements and as a key stakeholder providing input
  • Establish effective and open communication with all relevant stakeholders to ensure appropriate staffing and coverage
  • Coach, mentor and develop staff, including overseeing new employee onboarding and providing career development planning and opportunities
  • Demonstrated ability to effectively lead cross-functional teams and to autonomously influence business decisions where direct reporting line relationships do not exist
  • Ability to autonomously influence business decisions where direct reporting line relationships do not exist
  • Efficient use of resources through operational effectiveness.
  • In Partnership with RIO stakeholders, e.g., business process owners, SM, Strategists, serve and co-ordinate regulatory compliance activities ensuring the timely delivery of all regulatory compliance activities across the portfolio
  • Anticipates internal/external business and regulatory/ compliance issues that impact the Global Business Unit/Global Operating Unit or Sub Business Unit/Sub Operating Unit
  • Serves as advisor to others across Global Business Unit/Global Operating Unit or Sub Business Unit/Sub Operating Unit
  • 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 degree with 6 or more years or a Master's degree with 4 or more years in Life Sciences, Regulatory Affairs, Data Management, or related field.
  • Strong experience in Regulatory Affairs or Regulatory Operations and data governance, data management, or data quality role.
  • 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
  • Computer literacy in Microsoft 365/ Teams/Adobe Acrobat. Experience with publishing software, XML, Document Management, regulatory milestone reporting tools
  • Ability to embrace innovative technologies and process and drive implementation remotely
  • Articulate with strong analytical and interpersonal skills
  • Strong Project Managements Skills: Mastery of processes, tools and techniques for planning and monitoring multiple complex projects to established deadlines.
  • 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

ORGANIZATIONAL RELATIONSHIPS
SPaCE BPO's & Quality Oversight, RIDGE Reporting, RDV TA Leads
RESOURCES MANAGED
Project specific resources, Interns & vendor staff
Work Location Assignment: Hybrid (some office presence is required)
Last Day to Apply: November 2, 2026
The annual base salary for this position ranges from $124,400.00 to $207,400.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 17.5% 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.
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.
Pfizer endeavors to make www.pfizer.com/careers accessible 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 [email protected] . 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.
To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers .
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