
Regulatory Information Management Specialist
2 weeks ago
Job Title :
We are seeking a seasoned professional to fill the role of Regulatory Information Management Systems (RIMS) Support Engineer, with a focus on Veeva RIMS.
The ideal candidate will have hands-on experience with regulatory systems, eSubmissions, and compliance requirements for major health industries.
- Provide level 2/3 technical support for RIMS, primarily Veeva RIMS.
- Troubleshoot and resolve complex technical issues, ensuring minimal disruption to business operations.- Support regulatory applications and electronic submissions workflows.
- Collaborate with cross-functional teams including Business Analysts, QA, and Developers to deliver effective solutions.
- Maintain and update technical documentation for support processes and knowledge bases.
- Ensure compliance with global regulatory requirements, including FDA, MHRA, and Japanese eSubmission standards.
- Assist with RIMS system upgrades, configuration, and maintenance activities.
- Participate in RIMS implementation and integration projects as needed.
- Escalate unresolved issues to product vendors or development teams while maintaining ownership of follow-up.
- Communicate effectively with stakeholders and end users, ensuring clarity on issues and actions taken.],
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