Senior Specialist, Regulatory Affairs

Your Role At Baxter

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.

What You'll Be Doing

• Under general supervision, responsible for Veeva RIM, Promo Mats system ownership
• 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. Which includes tracking of status and progress of regulatory documentation, reviewing, editing and proofreading regulatory documentation, participating as an active team member of project teams as required, maintaining regulatory files in a format consistent with requirements as well as staying aware of regulatory requirements.
• 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

What You'll Bring

• Bachelor's degree in a scientific, life sciences, or related technical field
• 2+ years of regulatory experience
• Pharmaceutical industry experience preferred
• 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.
• Knowledge of regulations for FDA submission preferred.