Regulatory and Clinical Business Analyst
🏢 Company: Infosys Limited
📍 Location: Bangalore, India
🆔 Job ID / Reference Code: INFSYS-EXTERNAL-227357
💼 Work Experience: 3 – 15 Years
🎓 Educational Requirements:
Bachelor of Engineering / Technology / Computer Applications / Pharmacy
Master of Technology / Computer Applications / Pharmacy
📈 Service Line: Application Development and Maintenance
Position Summary
The Regulatory and Clinical Business Analyst will play a key role in supporting life sciences clients by delivering IT and regulatory solutions. The role involves deep understanding of clinical trials, drug safety, pharmacovigilance, and regulatory compliance systems while working closely with client teams, SMEs, and development teams throughout the project lifecycle.
Key Responsibilities
Essential Skills
2–10 years of total IT experience, with a minimum of 3 years in Clinical or Regulatory solutions for life sciences clients.
Strong understanding of the Life Sciences domain, including Clinical Trials, Drug Safety, and Pharmacovigilance.
Proficient with the Computer System Validation (CSV) tool and related regulatory requirements.
Exposure to the US Life Sciences market and regulatory landscape.
Experience in leading development teams, managing client interactions, and guiding projects through the full lifecycle.
Additional Responsibilities
Develop value-creating strategies and models that enable innovation, business growth, and profitability for clients.
Demonstrate good knowledge of software configuration management systems.
Stay updated with emerging technologies and industry trends.
Apply logical thinking and problem-solving skills to deliver quality solutions.
Understand financial processes and various project pricing models.
Assess current business processes, identify improvement areas, and suggest appropriate technology-driven solutions.
Leverage industry domain knowledge to enhance project delivery and value.
Exhibit strong client interfacing and team management capabilities.
Preferred Skills
Domain Expertise: Life Sciences → Clinical Trials, Compliance & Safety
Technology Expertise: Regulatory Compliance → Regulatory Compliance Systems
Ideal Candidate Profile
Technically strong and domain-aware professional with hands-on experience in Clinical and Regulatory IT solutions.
Strategic thinker with the ability to collaborate effectively across cross-functional teams.
Proactive in identifying opportunities for process improvement and digital innovation in the life sciences sector.
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