03 Nov
|
vueverse.
|
Maharashtra
03 Nov
vueverse.
Maharashtra
Title: ArisGlobal RIMS Hypercare Support
Years of Experience: 5+ Years
Work Location: Mumbai
Role Summary
We are looking for an experienced ArisGlobal RIMS Hypercare Support professional with 5+ years of experience in Regulatory Affairs, Regulatory Operations, and Regulatory Information Management Systems (RIM). The candidate should have hands-on experience with ArisGlobal LifeSphere RIMS, post-go-live support, incident management, data validation, and user support to ensure smooth system operations and stabilization.
Key Responsibilities
- Provide functional support for ArisGlobal RIMS across Regulatory Affairs and Regulatory Operations.
- Handle hypercare and post-go-live support following system implementation, upgrades, releases, or migrations.
- Support regulatory information management, including product details, registrations, submissions, licenses, regulatory commitments, and documentation.
- Troubleshoot user-reported functional and data-related issues and coordinate resolutions with technical teams and vendors.
- Monitor incidents, service requests, and defects, ensuring timely tracking and resolution.
- Support regulatory data validation, migration reconciliation, and data-quality activities.
- Assist with UAT, regression testing, business verification, and release activities.
- Support regulatory lifecycle activities, including new registrations, variations, renewals, and post-approval activities.
- Provide functional guidance to regulatory users and support user adoption.
- Maintain SOPs, work instructions, training materials, issue trackers, and resolution documentation.
- Coordinate with business SMEs, IT teams, and vendors to ensure smooth system stabilization and transition to BAU support.
Required Skills and Experience
- 5+ years of experience in Regulatory Affairs, Regulatory Operations, RIM, or pharmaceutical/biotechnology regulatory systems.
- Hands-on experience with ArisGlobal LifeSphere RIMS / ArisGlobal RIM platform .
- Experience in RIM implementation, migration, upgrades, post-go-live, or hypercare support.
- Strong understanding of pharmaceutical regulatory information and submission lifecycle processes.
- Experience in incident management, issue triage, defect tracking, and resolution coordination.
- Understanding of UAT, regression testing, change control, and release management.
- Experience in regulatory master data validation, data quality, and reconciliation.
- Ability to translate regulatory business requirements into functional/system support requirements.
- Valuable communication, stakeholder management, troubleshooting, and documentation skills.
Preferred
- Experience working with global pharmaceutical, biotechnology, CRO, or regulatory services organizations.
- Exposure to RIM system implementation and data migration projects.
- Experience supporting regulatory users during system stabilization and transition to BAU operations.
📌 ArisGlobal RIMS Hypercare Support (Maharashtra)
🏢 vueverse.
📍 Maharashtra