Group Analyst: Regulatory and Quality Applications

Aspen Pharma Group; Dubai; On-site; AED 180,000 - 250,000; Full time

Job summary

Aspen Pharma Group is looking for a Group Analyst to join its Dubai office. The role involves administering and configuring regulatory and quality systems like eQMS and RIMS, ensuring compliance with global regulatory standards. Candidates must have a Bachelor's degree in a related field and ITIL and Veeva Vault certifications. You will support quality teams with system access, documentation, user training, and manage system upgrades, contributing to process improvement initiatives.

Qualifications

• 3-5+ years experience administering Regulatory or Quality systems.
• Strong understanding of GxP and data integrity requirements.
• Ability to work collaboratively with cross-functional teams.

Responsibilities

• Administer quality systems for regulatory operations.
• Conduct routine system checks and maintain validation documentation.
• Train users and provide tier 2 and 3 application support.

Skills

Regulatory knowledge

ITIL incident management

Analytical skills

Troubleshooting capabilities

Compliance documentation

Education

Bachelor’s degree in Computer Science or related field

ITIL Foundation certification

Veeva Vault certification

Tools

eQMS platforms (Trackwise, Veeva QMS)

Audit & Compliance applications

Document Control systems

Job description

Job Purpose

Operational role within the Group Digital Technology team responsible for the administration, configuration, and support of systems used for regulatory, quality, and compliance operations across the organization. The Group Analyst serves as an application specialist supporting enterprise platforms such as eQMS, RIMS, Document Control, Audit & Compliance systems, and other regulatory/quality tools. The role ensures systems are maintained in a validated state, operated securely, and aligned with global regulatory standards, including GxP, 21 CFR Part 11, ISO 9001, and ISO 13485. The incumbent supports the Regulatory and Quality teams with reliable system access, troubleshooting, training, documentation, and coordination of system changes while working with IT, vendors, and auditors to maintain data integrity, compliance, and continuous improvement.

Key Responsibilities

• Perform day‑to‑day administration and configuration of Regulatory & Quality systems (eQMS, RIMS, DMS, Audit platforms).
• Manage user accounts, roles, permissions, and security groups.
• Configure workflows, rules, fields, and metadata according to approved designs.
• Lead system upgrades/releases per vendor quarterly release cycles.
• Build custom reports, implement Single Sign‑On and new security policies.
• Conduct routine system checks, maintenance tasks, and support validated state upkeep.
• Ensure systems are available and functioning for Quality and Regulatory processes (submissions, CAPAs, audits, deviations, SOPs, training).
• Support data‑integrity controls including audit trails, electronic signatures, and controlled documents.
• Assist in execution of controlled changes following QA‑approved processes.
• Maintain validation documentation (URS, IQ/OQ/PQ, change controls, risk assessments).
• Support internal and external audits, inspections, and regulatory reviews.
• Provide Tier 2 and Tier 3 support for application issues, escalating to managers, vendors, or IT infrastructure as necessary.
• Troubleshoot workflow failures, configuration errors, access issues, and data inconsistencies.
• Develop and deliver user training, onboarding materials, and system guides.
• Communicate system updates, enhancements, and release impacts to end users.
• Coordinate with vendors for issue resolution, small changes, and enhancement support.
• Track software licences, renewals, and small system contracts.
• Generate reports, dashboards, metrics, and compliance indicators.
• Monitor system performance, availability, and incident trends.
• Contribute to continuous improvement initiatives to enhance system reliability.
• Promote consistent global usage of Regulatory & Quality systems.

Required Qualifications

• Bachelor’s degree in Computer Science, Information Technology, Life Sciences, or related field.
• ITIL Foundation (required).
• Veeva Vault certification (required).
• GxP / CSV / 21 CFR Part 11 training (preferred).
• 3‑5+ years administering Regulatory, Quality, or other GxP‑validated systems.
• Experience supporting eQMS platforms (Trackwise, Veeva QMS, Esko Pulse), RIMS systems, Document Control systems (SharePoint DMS, Veeva Qdocs, OpenText), Audit & Compliance applications.
• Experience maintaining validated systems (URS, IQ/OQ/PQ, trace matrices).
• Familiarity with workflow design, role‑based security, reporting tools, and configuration rules.
• Strong understanding of GxP requirements, data integrity, ALCOA+, and validation processes.
• Knowledge of FDA 21 CFR Part 11, EMA, ICH, and relevant global regulatory guidelines.
• Experience analysing and interpreting regulatory guidelines and applying them to system operations.
• Strong knowledge of role‑based access administration and security controls.
• Application configuration, workflow administration, and user access management.
• Incident, problem, change, and request management using ITIL frameworks.
• Strong analytical and troubleshooting capability for application and workflow issues.
• Documentation discipline, including SOPs, work instructions, validation artefacts, and system logs.
• Ability to work collaboratively with Quality, Regulatory, and cross‑functional stakeholders.
• High attention to detail and disciplined approach to documentation and configuration control.
• Excellent communication skills, particularly in translating system concepts into business language.
• Ability to remain calm and effective under pressure or audit conditions.
• Proactive, collaborative, and committed to continuous improvement.
• High level of accountability and ownership of allocated tasks.
• Deep understanding of Regulatory Affairs and Quality Management processes.
• Knowledge of integration patterns between enterprise systems (e.g., Veeva, SAP, Argus).
• Understanding of electronic records/e‑signature regulations and data integrity requirements.

Key Performance Areas (KPA)

• System Administration & Configuration
• Regulatory & Quality Support
• Compliance, Validation & Documentation
• Issue Resolution & User Support
• Vendor & Stakeholder Coordination
• Data Governance & Reporting
• Service Delivery & Monitoring