Regulatory and Clinical Business Analyst
Job ID: INFSYS-EXTERNAL-242074
Company: Infosys Limited
Location: Bangalore, India
Employment Type: Full-time
Experience Required: 5–12 years
Job Overview
The Regulatory and Clinical Business Analyst will work within Life Sciences application development and maintenance projects, supporting regulatory compliance, clinical systems, and pharmacovigilance solutions. The role requires strong domain expertise in Life Sciences, regulatory systems, and clinical trial processes, along with hands-on experience in business analysis, stakeholder management, and technology-driven regulatory solutions.
Key Responsibilities
Clinical and Regulatory Domain Expertise
Work on Life Sciences domain areas including Clinical Trials, Drug Safety, and Pharmacovigilance
Support regulatory compliance system implementation and enhancement
Apply knowledge of US Life Sciences regulatory frameworks in project execution
Business Analysis and Solution Design
Analyze business requirements and translate them into technical specifications
Assess existing processes and identify opportunities for optimization
Design value-driven solutions that improve operational efficiency and compliance
Project Delivery and Team Leadership
Lead development teams across project lifecycle phases
Coordinate with client stakeholders, SMEs, and cross-functional teams
Support delivery of regulatory and clinical technology solutions
Regulatory Systems and Tools
Work with Computer System Validation (CSV) tools and frameworks
Ensure compliance with regulatory data integrity and validation standards
Support configuration and maintenance of regulatory compliance systems
Stakeholder Management
Interact directly with client teams for requirement gathering and validation
Provide consulting support on regulatory and clinical system improvements
Facilitate communication between technical and business teams
Required Qualifications
Bachelor of Engineering (BE) or equivalent qualification
Required Experience
5 to 12 years of total IT industry experience
Minimum 3 years of experience in Life Sciences domain (Clinical or Regulatory solutions)
Experience in regulatory compliance systems and clinical applications preferred
Key Skills Required
Regulatory Compliance Systems (Life Sciences IT)
Clinical Trials and Pharmacovigilance domain knowledge
Business Analysis and Requirement Gathering
Software Configuration Management
Client Interfacing and Stakeholder Management
Project and Team Leadership
Preferred Skills
Exposure to US Life Sciences regulatory market
Experience with CSV (Computer System Validation) tools
Strong analytical and problem-solving capabilities
Knowledge of industry trends and emerging Life Sciences technologies
Experience in financial and project delivery models
Role Highlights
Work on global Life Sciences regulatory transformation projects
Engage with leading pharmaceutical and clinical research clients
Drive innovation in regulatory compliance and clinical systems
Opportunity to lead cross-functional delivery teams in a high-impact environment
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