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EY

Senior Regulatory Compliance – Lab Digitisation – BA

EY

Senior role in Regulatory Compliance focusing on LIMS implementations for Life Sciences industries. Collaborating with stakeholders to optimize laboratory workflows and meet business objectives.

Posted 5/22/2026full-timeKochi • 🇮🇳 IndiaSeniorWebsite

Tech Stack

Tools & technologies
SQLVault

About the role

Key responsibilities & impact
  • Work closely with business stakeholders, laboratory personnel, and IT teams to gather and document LIMS requirements.
  • Gather and analyse business requirements related to LIMS functionality and enhancements.
  • Translate business needs into functional specifications and system configurations.
  • Configure, test, and validate LIMS functionalities to meet business needs.
  • Conduct impact analysis and risk assessments for LIMS changes and enhancements.
  • Serve as a liaison between business users and technical teams to ensure effective communication and system alignment.
  • Participate in business process mapping and workflow optimization to enhance LIMS utilization.
  • Assist in troubleshooting, identifying, and resolving LIMS-related issues.

Requirements

What you’ll need
  • B.E/B.Tech (Comp. Science/ Life Sciences/Chemistry/Information Technology or a related field)/Postgraduate in Science (Preferably in Chemistry/Biochemistry)
  • 5-8 years of experience with Big 4 or Multi-National Regulatory Compliance companies or Leading Life sciences / Pharmaceutical Industries
  • Strong understanding of laboratory workflows, sample lifecycle management, and data integrity principles.
  • Familiarity with analytical techniques, laboratory instrumentation, and regulatory standards.
  • Previous experience as a Business Analyst or System Administrator or Master Data Manager working with LIMS.
  • Hands-on experience in master data configuration within LIMS platforms.
  • Experience in system validation, testing, and documentation.
  • Exposure to Enterprise IT applications like LIMS, SAP, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, etc. in Pharmaceutical organization
  • Understanding of relational databases and SQL queries.
  • Experience with scripting or automation tools for LIMS is a plus.

Benefits

Comp & perks
  • Support, coaching and feedback from some of the most engaging colleagues around
  • Opportunities to develop new skills and progress your career
  • The freedom and flexibility to handle your role in a way that’s right for you

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools
LIMSmaster data configurationsystem validationtestingdocumentationSQLscriptingautomation toolsanalytical techniqueslaboratory instrumentation
Soft Skills
communicationcollaborationproblem-solvinganalytical thinkingrisk assessmentimpact analysisbusiness process mappingworkflow optimizationtroubleshootingliaison