P

Pfizer

Makes cancer drugs, vaccines and other medicines

Regulatory Data Excellence & Integrity Lead

Full-TimeDeadline 11/3/26
$124.4k - $207.4k/yr
Senior
Bachelor's, Master's
New York, NY, USA
HybridHybrid; some office presence is required.
Biology & BiotechRegulatory & Quality (Life Sciences)
No H1B Sponsorship

About the job

Requirements
  • A 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 a related field.
  • Strong experience in Regulatory Affairs or Regulatory Operations and data governance, data management, or data quality.
  • Proven experience managing colleagues and/or contractors within a matrix environment.
  • Robust understanding of the biopharmaceutical industry, regulatory and safety processes, and the external and internal environment.
  • Strong understanding of global regulatory submission and compliance requirements.
  • Detailed understanding of regulatory system structures and how they enable regulatory business needs and compliance, such as Veeva RIM, Liquent, and Lorenz.
  • Detailed understanding of regulatory subject matter expert processes and needs across the lifecycle, including centralized registration procedures, IDMP, CMC, and artwork/labeling.
  • Computer literacy in Microsoft 365, Teams, and Adobe Acrobat; experience with publishing software, XML, document management, and regulatory milestone reporting tools.
  • Ability to embrace innovative technologies and processes and drive implementation remotely.
  • Strong analytical and interpersonal skills.
  • Mastery of project management processes, tools, and techniques for planning and monitoring multiple complex projects to established deadlines.
  • Experience with master data management and data quality improvement, and aptitude for leveraging data to drive efficiency and innovation.
  • Demonstrated knowledge of or experience with strategic business planning and operations.
  • Ability to communicate complex information and analyses, and difficult messages, to varied audiences verbally and in writing.
  • Cross-functional and global business perspective; demonstrated business acumen, organizational management skills, ability to handle multiple demands and tight timelines, and ability to interact professionally and discreetly with all organizational levels.
  • Proven ability to influence and lead cross-functional teams without direct authority.
  • Ability to deal with ambiguity, creativity, and adapt in real time.
  • Candidates must be authorized to be employed in the United States by any employer and have permanent work authorization in the United States.
Responsibilities
  • Oversee global data management activities and stewardship of regulatory milestones and license status conformance within regulatory systems.
  • Champion innovation and appropriately challenge the status quo to enhance processes that affect cross-functional teams and business units.
  • Influence senior management decisions affecting business direction and support global regulatory data strategies across global business units and markets.
  • Lead the evolution of data management and quality oversight in partnership with business and digital partners.
  • Ensure data integrity through audit and verification checks and quality control of data timeliness, accuracy, and completeness.
  • Develop key performance indicators to ensure accurate and timely execution of improvement initiatives and increased compliance in relevant processes.
  • Liaise with business process owners, ensure interpretations of compliance requirements, and provide input as a key stakeholder.
  • Establish effective communication with relevant stakeholders to ensure appropriate staffing and coverage.
  • Coach, mentor, and develop staff; oversee new employee onboarding and provide career development planning and opportunities.
  • Lead cross-functional teams and influence business decisions where direct reporting relationships do not exist.
  • Use resources efficiently through operational effectiveness.
  • Partner with RIO stakeholders, including business process owners, senior management, and strategists, to serve and coordinate regulatory compliance activities and ensure timely delivery across the portfolio.
  • Anticipate internal and external business and regulatory or compliance issues affecting the Global Business Unit, Global Operating Unit, Sub Business Unit, or Sub Operating Unit.
  • Serve as an advisor across the Global Business Unit, Global Operating Unit, Sub Business Unit, or Sub Operating Unit.
  • Develop ideas and lead or co-lead complex projects across a Sub Business Unit or Sub Operating Unit.
  • Develop and manage plans to achieve objectives.
  • Apply skills and domain expertise to contribute to work within a Sub Business Unit or Sub Operating Unit.
  • Make decisions that require innovative options to resolve complex problems and operate within general business-line or functional guidance.
  • Lead operational teams within and across work teams and departments.
  • Complete, oversee, or support strategic initiatives that advance regulatory data management, including business transformation, change management, capability building, business efficiency efforts, complex process redesign, and program management for global or regional projects.
  • Liaise with and influence partner lines to safeguard patient safety through high-quality data management across Pfizer systems.

About the company

Pfizer discovers, makes, and sells prescription medicines and vaccines for patients, doctors, and governments worldwide, with large businesses in vaccines, cancer, heart disease, and rare diseases. In 2020, its COVID-19 shot, developed with German partner BioNTech, became the first COVID-19 vaccine authorized in the United States. Its scientists find drug candidates and run clinical trials to prove they are safe and effective, and Pfizer then manufactures approved products in its own plants, earning most of its money from patented drugs before cheaper generic copies arrive. Pfizer was founded in 1849 as a chemicals business in Brooklyn and is based in New York City.

Company Size

10,001+

Company Stage

IPO

Headquarters

New York City, New York

Founded

1849

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Simplify's Take

What believers are saying

  • Newer drugs carry the business: launched and acquired products grew 18% operationally in Pfizer's August 2026 quarterly report.
  • The outlook improved: in August 2026, Pfizer raised its 2026 revenue guidance to $60.5 billion to $62.5 billion.
  • Vaccine scientists get room to grow: Pfizer's $470 million Pearl River, New York research expansion is designed for 370 workers.

What critics are saying

  • Expect more site cuts: in November 2025, Pfizer moved to shrink Swiss staff from about 300 to roughly 70.
  • Generics will erase sales: Pfizer expects patent losses to cut $17 billion to $18 billion of yearly revenue through 2028.
  • Pfizer is chasing obesity leaders: Metsera's monthly shot showed 12.3% weight loss at 28 weeks in February 2026 data.

What makes Pfizer unique

  • Pfizer bought its way into cancer: its Seagen buyout added antibody-drug conjugates, which carry chemotherapy straight to tumors.
  • Pfizer is betting on monthly obesity shots: Metsera's berobenatide is dosed once a month, unlike weekly Wegovy and Zepbound.
  • Pfizer leans on one partnered heart drug: blood thinner Eliquis, sold with Bristol Myers Squibb, brings about 14% of revenue.

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Benefits

  • Health Insurance
  • Dental Insurance
  • Vision Insurance
  • 401(k) Retirement Plan
  • 401(k) Company Match
  • Paid Vacation
  • Paid Sick Leave
  • Paid Holidays
  • Hybrid Work Options
  • Relocation Assistance

Growth & Insights and Company News

6 month growth

-3%

1 year growth

-2%

2 year growth

-2%
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