Regulatory and Clinical Business Analyst
Job Reference Code: INFSYS-EXTERNAL-235346
Location: India (Global Client Exposure – US Life Sciences Market)
Experience Required: 5–15 Years
Employment Type: Full-Time
Service Line: Application Development and Maintenance
Industry: Life Sciences | Clinical Research | Regulatory Affairs
Role Overview
We are seeking an experienced Regulatory and Clinical Business Analyst to support global Life Sciences clients across clinical trials, regulatory compliance, and pharmacovigilance domains. This role requires a strong blend of business analysis, domain expertise, and IT solution delivery, with direct exposure to US Life Sciences markets.
The ideal candidate will act as a strategic partner to stakeholders, translating clinical and regulatory requirements into scalable, compliant technology solutions while driving process optimization and business value.
Key Responsibilities
Clinical & Regulatory Domain Expertise
Analyze and document business requirements for clinical trials, drug safety, and pharmacovigilance systems
Support initiatives related to regulatory compliance, safety reporting, and clinical data workflows
Apply strong understanding of Life Sciences processes, including Clinical Trials, Drug Safety, and Compliance & Safety
Business Analysis & Solution Delivery
Collaborate with client stakeholders, subject matter experts, and cross-functional IT teams throughout the project lifecycle
Translate business needs into functional and technical specifications for application development and maintenance
Assess current-state processes, identify gaps, and recommend technology-driven improvements
Support validation activities with a strong understanding of Computer System Validation (CSV) tools and processes
Project & Team Leadership
Lead and mentor development teams while coordinating closely with client teams and SMEs
Support project planning, execution, and delivery across multiple engagement models
Ensure adherence to quality, compliance, and delivery timelines
Strategic & Financial Acumen
Develop value-driven strategies and solution models that enable clients to innovate, scale, and improve profitability
Demonstrate understanding of financial processes across project types and pricing models
Support decision-making through data-driven insights and logical problem-solving
Required Skills & Experience
Experience:
5–15 years of total IT industry experience
Minimum 3 years of hands-on experience in Clinical or Regulatory solutions for Life Sciences clients
Proven exposure to the US Life Sciences market
Experience working across the full software development life cycle (SDLC)
Technical & Domain Skills:
Strong knowledge of Life Sciences domains including Clinical Trials, Drug Safety, and Pharmacovigilance
Familiarity with Computer System Validation (CSV) tools and compliance processes
Working knowledge of software configuration management systems
Awareness of emerging technologies and current industry trends
Professional Competencies:
Excellent analytical, logical thinking, and problem-solving skills
Strong client interfacing and stakeholder management capabilities
Ability to collaborate effectively across technical and business teams
Experience in project and team management
Education
Bachelor of Engineering (BE) or equivalent technical qualification
Preferred Skills
Deep domain expertise in Life Sciences – Clinical Trials
Experience in Compliance & Safety systems
Exposure to regulated environments governed by global health authorities
Why Join This Role
This role offers the opportunity to work at the intersection of Life Sciences, technology, and regulatory compliance, supporting global clients and complex clinical ecosystems. You will play a key role in driving digital transformation, ensuring regulatory readiness, and delivering high-impact solutions in a highly regulated industry.
Apply now on thepharmadaily.com
Advance your career in Clinical, Regulatory, and Life Sciences Business Analysis.
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Siliguri |Illinois :
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Andover | Billerica | Boston | Cambridge | Devens | Lexington | Massachusetts | Medford and Somerville | Rockland |Wisconsin :
Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
Arizona | Buffalo Grove | Clayton | Downers Grove | fairmont | Georgia | Keene | Michigan | Mt. Pleasant | New Jersy | OH | Piedmont | Salisbury | United States | Whitesboro | Winston-Salem |Georgia :
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Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Tallinn |Hà Nội :
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Kyiv |Lima Region :
Lima |France :
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South Africa | Midrand |Nišava District :
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