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Baxter Logo Baxter · IT - Administration

Senior Specialist, Regulatory Affairs

United States, Deerfield Employment contract 88000.00 - 121000.00 USD / Year · Job Posted June 09, 2026
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Job Description

The Senior Specialist resides within the Global Regulatory Affairs Systems Group. This group owns the Regulatory Information Management (RIM) and Advertising and Promotions (Ad Prom) process, and the system that enables the process (Veeva RIM and Promo Mats). An ideal candidate will have strong working experience with RIM and Ad Prom systems to understand the current business process.

Job Responsibility

  • Perform Veeva RIM business admin activities, including managing data, updates to system and participate in data governance activities
  • Working with project teams on various data initiatives, addressing data challenges and gaps in current system
  • Identify areas for improvement/modification
  • Compile regulatory documents for FDA 2253 submission
  • Develop training material and liaise with cross function teams
  • Understand internal global processes supporting Regulatory systems
  • Coordinates and drives deliverable preparation
  • develops and maintains process models using standard methods and tools
  • manages and tracks communications, metrics, and reporting-related processes
  • Develops, executes and implements business processes for data integration, maintenance and remediation
  • Conducts impact assessments, develops strategies for implementing and maintaining data quality

Requirements

  • Bachelor's degree in a scientific, life sciences, or related technical field
  • 2+ years of regulatory experience
  • Strong understanding of Veeva software (RIM and Promo Mats) systems
  • Strong written and verbal communication skills, ability to organize, prioritize and meet deadlines
  • Strong analytical skills, including digital competency
  • Strong technical systems skills (i.e. databases, XML and Microsoft Office 365 including SharePoint, Power Automate and Excel)
  • Proofreading and editing skills
  • Ability to contribute to multiple projects from a regulatory affairs perspective
  • Ability to multitask and problem solve
  • Applicants must be authorized to work for any employer in the U.S.

Nice to have

  • Pharmaceutical industry experience preferred
  • Knowledge of regulations for FDA submission preferred

What we offer

  • Medical and dental coverage that start on day one
  • Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
  • Employee Stock Purchase Plan (ESPP)
  • 401(k) Retirement Savings Plan (RSP)
  • Flexible Spending Accounts
  • Educational assistance programs
  • Time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave
  • Commuting benefits
  • Employee Discount Program
  • Employee Assistance Program (EAP)
  • Childcare benefits
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