Group Administrator: Regulatory and Quality Applications

Aspen Holdings

Job Purpose:

The Group Administrator: Regulatory and Quality Applications is an operational role in the Group Digital Technology team, responsible for providing day-to-day application support, issue resolution, and user assistance for the Regulatory and Quality Application which includes primarily Veeva and related systems like Esko Pulse, TVT, Argus PV and Track wise Digital. This role is support-focused, ensuring that Regulatory Affairs teams can operate efficiently and in compliance using the Regulatory IT platforms. The Administrator acts as a first line of support for users, manages incidents, service requests and changes, coordinates with internal Regulatory Application Analyst / Specialist, Internal IT Teams and Vendor (like Veeva) for issue escalation, and plays a critical role in maintaining system stability and user satisfaction. Basic Veeva system configuration and reporting skills are essential.

KPA:

Application Support and Troubleshooting

Provide 1st and 2nd line support for users of the Regulatory applications, E.g. Registrations, Submissions, Archive, CRM and Safety.

Monitor support queues, investigate and resolve incidents, log service requests, and ensure timely follow-up and closure.

Troubleshoot common issues such as document upload failures, user access problems, metadata mismatches, and workflow errors.

Ensure SLAs are met, and tickets are closed on time (Incidents, Requests, Change & Problem)

Ensure Problem Management is followed, and RCA is provided for major & recurring incidents

Follow GxP & CSV methods and ensure system stays in validated state with no deviations

User Access Management

Manage user onboarding/offboarding, access rights, and role-based permissions in compliance with internal SOPs.

Assist with system audits of user access and role reviews to ensure regulatory compliance.

Incident Management & Escalation

Collaborate with other team members, management, and service providers to escalate and resolve complex technical issues.

Track and manage open issues using ticketing tools (e.g., ServiceNow), ensuring timely updates and user communication.

System Monitoring & Maintenance

Perform daily health checks and monitor system performance to ensure uptime and data integrity.

Track usage metrics, system logs, and user behaviour to proactively identify potential issues.

Documentation & Training

Maintain system support documentation including troubleshooting guides, FAQ articles, and job aids.

Assist in user training sessions and creation of quick reference materials to improve adoption and reduce support requests.

Release Readiness & Testing

Review release notes (E.g. Veeva Release notes) and assist in testing new features and updates.

Support quarterly releases by validating critical functionality and reporting potential issues before go-live.

Continuous Improvements

Collect feedback from end-users to identify pain points and suggest system enhancements.

Participate in projects related to system upgrades, enhancements, or integrations (e.g., with Argus, ERP, or EDMS systems).