Regulatory and Clinical Business Analyst

Infosys; Bengaluru; Hybrid; INR 1,200,000 - 1,800,000; Full time

Job summary

Infosys is seeking a qualified professional with 5–12 years of IT experience in Life Sciences consulting, regulatory compliance, and solution design. The role involves leading small projects, interfacing with clients, and contributing to solution demos and POCs in a regulatory context.

The candidate will work on clinical trials, drug safety, pharmacovigilance, and CSV tool workflows, while aligning with business goals in the US Life Sciences market and overall digital transformation initiatives.

Qualifications

• Bachelor of Engineering as educational requirement.
• Experience in Life Sciences domain (Healthcare/Regulatory).
• Familiarity with CSV tools and regulatory standards.

Responsibilities

• As part of the Infosys consulting team, diagnose problems and design solutions to delight clients.
• Own parts of the proposal and contribute inputs for solution design.
• Plan configuration activities and configure the product as per design.

Skills

Regulatory Compliance

Life Sciences

Client Interfacing

Education

Bachelor of Engineering

Tools

CSV tool

Job description

A day in the life of an Infoscion

• As part of the Infosys consulting team, your primary role would be to get to the heart of customer issues, diagnose problem areas, design innovative solutions and facilitate deployment resulting in client delight.
• You will develop a proposal by owning parts of the proposal document and by giving inputs in solution design based on areas of expertise.
• You will plan the activities of configuration, configure the product as per the design, conduct conference room pilots and will assist in resolving any queries related to requirements and solution design
• You will conduct solution/product demonstrations, POC/Proof of Technology workshops and prepare effort estimates which suit the customer budgetary requirements and are in line with organization's financial guidelines
• Actively lead small projects and contribute to unit-level and organizational initiatives with an objective of providing high quality value adding solutions to customers. If you think you fit right in to help our clients navigate their next in their digital transformation journey, this is the place for you! Roles & Responsibilities5-12 years of total IT industry experience, with at least 3 years in Clinical or Regulatory solutions for Life Sciences clients.
• Should be well familiar with Life Sciences Domain - Clinical Trials, Drug Safety, Pharmacovigilance
• Familiarity with the complete working of CSV tool
• Exposure to US Life Sciences market
• Experience of leading development team, working with client teams/SMEs and leading them through the project life cycle.
• Primary skills:Technology->Regulatory Compliance->Regulatory Compliance System
• Ability to develop value-creating strategies and models that enable clients to innovate, drive growth and increase their business profitability
• Good knowledge on software configuration management systems
• Awareness of latest technologies and Industry trends
• Logical thinking and problem solving skills along with an ability to collaborate
• Understanding of the financial processes for various types of projects and the various pricing models available
• Ability to assess the current processes, identify improvement areas and suggest the technology solutions
• One or two industry domain knowledge
• Client Interfacing skills
• Project and Team management
• Educational RequirementBachelor of Engineering
• Preferred SkillsDomain->Healthcare->Regulatory Compliance & Standards,Technology->Life Sciences->Regulatory Systems
• Service LineApplication Development and Maintenance