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At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.
Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.
Here, you will find more than just a job—you will find purpose and pride.
Job Description
This role resides within the Regulatory Operations - Systems and Submissions Operations organization. The position provides centralized, hands-on support for regulatory systems, compliance, RIM data quality, registration-data maintenance, user support, and operational process execution. The role partners with Global Regulatory Affairs (GRA), Pharmacovigilance (PV), Global IT, and business stakeholders to maintain accurate, complete, and compliant regulatory information.
Essential Duties and Responsibilities
Support implementation and maintenance of Regulatory Operations procedures and work instructions, identify process gaps, and help ensure consistent execution and compliance across regulatory systems activities.
Compile and monitor operational and compliance metrics for RIM and related regulatory systems; identify missing, late, inaccurate, or inconsistent data; document findings; and escalate unresolved risks.
Provide day-to-day business administration and user support for Veeva Vault RIM, PromoMats, and other Regulatory Affairs systems, including access support, issue intake, documentation, troubleshooting coordination, and enhancement requests.
Provide business requirements, user input, testing support, and operational subject-matter expertise for automation, Microsoft Copilot, AI, and other digital improvements affecting regulatory data and workflows. Create, test, refine, document, and maintain reusable Copilot prompts that improve turnaround time, consistency, and quality for defined Regulatory Operations activities.
Serve as an operational point of contact for PV-related RIM questions and data gaps; investigate discrepancies, coordinate corrections, and support timely communication of registration-status changes and supporting documentation.
Maintain awareness of evolving regulatory and business requirements related to regulatory systems, records, data management, data quality, and controlled processes; assess and communicate operational impacts while driving continuous improvement.
Partner with Global IT and business users on system upgrades, enhancements, and validation activities. Develop, revise, and execute User Acceptance Testing (UAT) scripts; document issues and resolutions; and verify that data integrity and system functionality are maintained.
Maintain regulatory support systems, libraries, dictionaries, controlled reference data, trackers, mailboxes, and system documentation to support accurate and consistent regulatory information management.
Process registration-update requests through defined intake forms or mailboxes; track open items and follow up to support timely completion.
Partner with RIM SMEs to develop and deliver training, onboarding, and ongoing support for new and existing RIM users.
Qualifications
Bachelor's degree or country equivalent in Life Sciences, Regulatory Affairs, Information Systems, Business, or a related discipline.
5+ years of experience in Regulatory Affairs, Regulatory Operations, regulatory systems, data management, or another regulated pharmaceutical or medical-device environment.
Strong working knowledge of Veeva Vault RIM including business administration, user support and data…