UAT Tester - Regulatory Affairs Applications

Job Location - Chennai & Hyderabad

Keywords Safety Systems, Regulatory submissions, labeling, publishing, RIMS (Veeva, etc.)

Roles and Responsibilities

Must Have

• Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Regulatory Sciences, or Computer Science.
• 4–8 years of experience in IT testing/validation, with 2–4 years in Regulatory Affairs systems
• Work with Regulatory Affairs, Publishing, Labeling, and IT teams to understand business processes and URS (User Requirement Specifications).
• Hands-on experience with Regulatory applications (e.g., Veeva Vault RIM, Lorenz docuBridge, Liquent InSight, Extedo eCTDmanager, or similar).
• Develop UAT strategy, test plans, test cases, and traceability matrices aligned with RA workflows.
• Execute UAT test scripts, document results, log defects, and track resolution with IT/vendors.
• Validate workflows related to submission planning, document authoring, publishing, eCTD compilation, electronic submissions, and labeling/artwork review.
• Perform regression testing for system upgrades, patches, and integrations with DMS, QMS, Safety, and Clinical systems.
• Verify compliance with 21 CFR Part 11, GAMP 5, ICH, and regional regulatory submission guidelines.
• Validate metadata management, version control, and controlled vocabularies for submissions.
• Ensure readiness for global submissions (NDA, MAA, IND, CTA, ANDA, variations, renewals).
• Support end-user readiness, training, and sign-off for UAT completion.
• Document deviations, manage defect triage, and ensure timely closure.
• Provide UAT summary reports, support release readiness decisions, and maintain audit trail.
• Contribute to audit/inspection readiness by maintaining UAT documentation.
• Identify process improvement opportunities and support test automation initiatives.

Good to Have (secondary skills)

• Strong knowledge of Regulatory submissions, eCTD structure, publishing workflows, labeling, and lifecycle management.
• Experience with UAT methodology, SDLC, and CSV (Computer System Validation).
• Familiarity with global regulatory guidelines (FDA, EMA, MHRA, PMDA, Health Canada).
• Proficiency with defect tracking tools (JIRA, HP ALM, Veeva QMS).
• Excellent communication, documentation, and cross-functional collaboration skills.
• Strong analytical and problem-solving mindset.

Communication

• Immaculate communication and handles multiple clients/ projects
• Works in Consulting capacity Regulatory Affairs Applications

Best Regards,

Sanjay Kumar