Regulatory Information Management Analyst
$28,160–$42,240 year
RemoteSlovakia
Job Summary
Serve as the primary point of contact for internal users of Regulatory Information Management systems, providing support and issue resolution. Create and maintain submission structures, regulatory records, and business data attributes within the RIM environment. Build and manage system templates, including submission assembly templates and related configurations. Perform data entry, data cleansing, and master data governance activities to ensure data accuracy and integrity. Support implementation and sustainment activities associated with the RIM modernization program. Participate in project meetings, providing status updates, identifying risks, and supporting mitigation activities for assigned deliverables. Monitor adherence to RIM standards, procedures, and work instructions to support regulatory compliance requirements. Identify opportunities to improve system processes, data quality, and user experience through continuous improvement initiatives.
Required Qualifications
- Bachelor's degree in Life Sciences, Public Health, Business, or a related discipline
- 2+ years of experience supporting Regulatory Information Management systems, Regulatory Affairs processes, or master data management
- Master's degree and 1+ year of relevant experience
- Experience maintaining business data, regulatory records, or master data in enterprise systems
- Experience supporting end users, managing requests, or resolving system-related issues
- Proficiency using Microsoft Office applications, including Excel
- Demonstrated ability to manage multiple assignments while maintaining accuracy and attention to detail
- This position is based in Bratislava, Slovakia
- No travel is required for this role
Desired Qualifications
- Experience working with Regulatory Information Management platforms in a medical device, pharmaceutical, or life sciences environment
- Knowledge of the regulatory affairs lifecycle and regulatory submission processes
- Experience with data governance, data quality management, or system implementation projects
- Experience collaborating with cross-functional teams including Regulatory Affairs and Information Technology
- Experience identifying and implementing process improvements that enhance system effectiveness or data quality
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