R&D Regulatory Systems Manager

Job Summary

Working remotely on a full-time basis, the R&D Regulatory Systems Manager will manage technology needs in Regulatory Affairs and R&D, ensuring compliance with global processes and systems while leveraging strong Veeva RIM architecture and development expertise.

Key responsibilities

• Provide expertise in digital capabilities supporting global R&D business processes and monitor health authority requirements for system impact
• Collaborate with business users to translate needs into technical requirements and implement solutions according to industry best practices
• Lead administration and enhancements of Veeva RIM Vaults, ensuring successful project management and compliance with regulations

Required qualifications

• Bachelor's degree in science, IT, or a related field; advanced degrees are a plus
• 7 years of regulatory business process knowledge with hands-on experience in configuring and integrating Veeva RIM Vaults
• 5 years of experience in software design, development, and system integrations
• Experience in the pharmaceutical industry with a solid understanding of R&D and regulatory business processes
• Hands-on experience in validated GxP environments and knowledge of GCP, EMA, and FDA regulations