Experience
8 - 12 yrs
Job Location
Bengaluru, India
Vacancy
1
Designation
Senior Regulatory Compliance Manager
Job Type
ONSITE
Job Description
EY GDS Consulting Enterprise Risk (ER) Regulatory Compliance Manager LABS Business Analyst
As part of our EY-ER- Regulatory Compliance team, you will help the clients by understanding their business needs and delivering solutions in accordance with the EY guidelines & methodologies. As a Regulatory Compliance Manager actively establish, maintain and strengthen internal and external relationships. In line with our commitment to quality, you ll consistently drive projects to completion with high quality deliverables, achieve operational efficiency, proactively identify and raise risks with the client as well as EY senior management team and lead internal initiatives.
The opportunity
We are seeking an experienced Manager with deep expertise in Laboratory Digitalisation to lead regulatory strategy and IT-enabled transformation initiatives in regulated GxP environments. This role requires strong consulting skills, industry knowledge, and the ability to translate regulatory strategy into scalable, compliant solutions for global clients.
Role Overview
As a Manager at Regulatory Compliance, you will lead Digital Laboratory initiatives in regulated GxP environments, leveraging your deep expertise in Laboratory Information Management Systems (LIMS), Electronic Laboratory Notebooks (ELN), Laboratory Execution Systems (LES), and strong consulting capabilities.
Your primary responsibility will be to partner with clients to understand their laboratory business needs and translate strategic objectives into integrated, compliant, and practical digital lab solutions. You will play a pivotal role in establishing and nurturing relationships across internal teams and external stakeholders, ensuring alignment with EY s commitment to data integrity, quality, and regulatory compliance.
This is a leadership role that demands strategic thinking, strong stakeholder engagement, and a passion for delivering excellence across complex laboratory operations in a highly regulated environment.
Your key responsibilities
Client Responsibilities
- Lead and oversee Digital Lab initiatives, including LIMS, ELN, and LES implementations, upgrades, and optimizations in regulated laboratory environments
- Elicit, analyze, and document business requirements for LIMS implementations/enhancements (LabWare, Benchling, STARLIMS), translating laboratory processes into functional specifications and user stories.
- Act as the bridge between business and technical teams, ensuring accurate mapping of lab workflows (sample management, testing, stability, reporting) into system configurations and solution designs.
- Drive process optimization and standardization by identifying gaps, redundancies, and improvement opportunities across laboratory operations and aligning with industry best practices.
- Support system implementation and validation activities by defining test scenarios, coordinating UAT, ensuring traceability, and maintaining compliance with GxP, 21 CFR Part 11, and data integrity requirements.
- Facilitate stakeholder engagement and change management through workshops, training, documentation, and user support to drive adoption of LIMS solutions across labs.Partner with clients to understand laboratory operations and translate business and compliance requirements into integrated digital lab solutions and their respective configurations
- Drive requirements gathering, system configuration, data migration, and integrations across lab systems, instruments, and enterprise platforms
- Ensure data integrity, traceability, and compliance with GxP, 21 CFR Part 11, Annex 11, and internal SOPs
- Guide clients through CSV / CSA / risk based validation activities for digital lab systems
- Support audits, inspections, and regulatory assessments related to laboratory systems
- Identify opportunities for process harmonization, standardization, and digital enablement across laboratories
People Responsibilities
- Lead, coach, and mentor Digital Lab consultants, validation analysts, and technical team members
- Manage work allocation across LIMS, ELN, and LES engagements, ensuring quality delivery and adherence to timelines
- Conduct performance reviews, feedback, and development planning
- Build and strengthen Digital Lab and laboratory systems capabilities within the team
- Support hiring, onboarding, training, and knowledge transfer initiatives
- Foster a culture of quality, accountability, and continuous improvement
Decision-Making Responsibilities:
- Make informed decisions on delivery approach, validation strategy, and risk mitigation for digital lab programs
- Assess system, data, and compliance risks and proactively escalate issues to clients and EY leadership
- Support leadership in workforce planning, solution design, and practice development for Digital Lab offerings
- Guide decisions on vendor coordination, system design tradeoffs, and implementation timelines
- Apply structured and analytical thinking to improve delivery efficiency and client outcomes.
Other Responsibilities
- Contribute to business development, proposals, and client presentations related to Digital Lab initiatives
- Support inspection readiness, mock audits, and CAPA activities
- Stay current with regulatory expectations, industry trends, and emerging digital lab technologies
- Promote adoption of automation, analytics, and innovation within laboratory operations
- Collaborate with Quality, IT, Regulatory, and Manufacturing teams to deliver integrated solutions
- Uphold EY s standards for ethics, quality, and compliance.
Skills and attributes for success
- Strong understanding of regulated laboratory environments and quality driven operations
- Ability to identify process gaps, operational risks, and improvement opportunities
- Structured and analytical approach to problem solving and decision making
- Strong stakeholder and client management skills
- Ability to work effectively
No Referrers Available
There are currently no referrers available for this job. You can still apply, will let you know once there is any referrer available.