Principal Specialist, Regulatory Affairs

• 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.

• 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 administration.
• Knowledge of regulatory operations, registration-data maintenance, controlled documentation, data-quality practices, and applicable regulatory requirements.
• Experience supporting system implementations, upgrades, User Acceptance Testing (UAT), validation activities, test-script execution, defect documentation, and resolution follow-up.
• Experience with Microsoft Copilot, AI solutions, or automation tools is desirable. Demonstrated familiarity with prompt creation, prompt testing, reusable prompt libraries, and responsible application of Copilot to regulated business processes is preferred.
• Demonstrated ability to identify data and compliance gaps, investigate discrepancies, manage multiple priorities, work independently, collaborate across functions, and resolve or escalate issues when necessary.
• Strong written and verbal communication, organization, collaboration, and user-support skills.
• Ability to work effectively in a multinational and multicultural matrix environment.

We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The minimum salary for this position is €36.800 annually. Your initial pay could be at the minimum or higher based on skills and expertise, experience, and other relevant factors, all of which are subject to change. This position may also be eligible for competitive benefits, discretionary bonuses, and/or long-term incentive. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview.