Principal Specialist, Regulatory Affairs

About the role

Baxter is hiring a Principal Specialist, Regulatory Affairs in San Gwann, Malta, within its Regulatory Operations - Systems and Submissions Operations organization. The role provides centralized, hands-on support for regulatory systems, compliance, RIM data quality, registration-data maintenance, user support and operational process execution, partnering with Global Regulatory Affairs, Pharmacovigilance, Global IT and business stakeholders.

Key responsibilities

• Support implementation and maintenance of regulatory operations procedures and work instructions, and identify process gaps
• Compile and monitor operational and compliance metrics for RIM, flagging missing, late or inaccurate data and escalating unresolved risks
• Provide day-to-day business administration and user support for Veeva Vault RIM, PromoMats and other regulatory systems, including access support, issue intake, troubleshooting and enhancement requests
• Support automation, Microsoft Copilot and AI initiatives, create and maintain reusable Copilot prompts, and act as operational point of contact for PV-related RIM questions
• Partner with Global IT on system upgrades and validation, develop UAT scripts and document issues and resolutions
• Maintain regulatory support systems, libraries, dictionaries, controlled reference data, trackers, mailboxes and documentation
• Process registration-update requests through intake forms or mailboxes and partner with RIM SMEs on training and onboarding

Required profile

• Bachelor's degree or 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 a regulated pharmaceutical or medical-device environment
• Ability to work independently, manage multiple priorities, collaborate across functions and work in a multinational, multicultural setting

Required skills

• Strong working knowledge of Veeva Vault RIM, including business administration, user support and data administration
• Knowledge of regulatory operations, registration-data maintenance, controlled documentation and data-quality practices
• Experience with system implementations, UAT, validation, test scripts and defect resolution
• Experience with Microsoft Copilot, AI solutions or automation tools is desirable, with familiarity with prompt creation and reusable prompt libraries preferred

What we offer

• Minimum salary of EUR 36,800 per year, with possible higher pay based on skills and experience
• Possible eligibility for competitive benefits, discretionary bonuses and/or long-term incentives