Regulatory and Clinical Business Analyst
Job ID: INFSYS-EXTERNAL-239523
Category: Application Development and Maintenance
Industry: Life Sciences / Pharmaceutical IT
Experience Required: 5–12 Years
Location: India
Job Overview
We are seeking a highly experienced Regulatory and Clinical Business Analyst with strong expertise in Life Sciences technology solutions. This role requires deep domain knowledge in Clinical Trials, Drug Safety, and Pharmacovigilance, along with hands-on experience in regulatory systems and Computer System Validation (CSV).
The ideal candidate will act as a bridge between business stakeholders, regulatory teams, and technical development teams to deliver compliant, scalable, and innovative IT solutions for global Life Sciences clients.
Key Responsibilities
Clinical & Regulatory Domain Expertise
Provide business analysis support for Clinical Trials, Drug Safety, and Pharmacovigilance solutions.
Work closely with Life Sciences clients, SMEs, and regulatory stakeholders to gather and translate business requirements into functional specifications.
Ensure compliance with regulatory frameworks applicable to US and global Life Sciences markets.
Demonstrate familiarity with Computer System Validation (CSV) processes and compliance requirements.
Business Analysis & Solution Design
Assess current business processes and identify improvement opportunities.
Propose technology-driven solutions to enhance regulatory compliance, operational efficiency, and business performance.
Develop value-driven strategies and business models that support innovation and profitability.
Support system configuration management and ensure adherence to software development best practices.
Project & Stakeholder Management
Lead development teams and coordinate cross-functional project activities throughout the project lifecycle.
Manage client interactions, requirement workshops, and solution validation sessions.
Collaborate effectively with global teams and stakeholders to deliver high-quality outcomes within defined timelines.
Understand project financial models, pricing strategies, and commercial considerations in client engagements.
Technology & Industry Awareness
Stay updated on emerging technologies, digital transformation trends, and regulatory technology advancements within the Life Sciences sector.
Apply logical thinking and analytical problem-solving skills to address complex business and technical challenges.
Required Qualifications
Bachelor of Engineering or equivalent technical degree.
5–12 years of total IT industry experience.
Minimum 3 years of experience working on Clinical or Regulatory solutions for Life Sciences clients.
Strong understanding of Clinical Trials, Compliance & Safety, Drug Safety, and Pharmacovigilance domains.
Experience working with US Life Sciences market requirements.
Proven experience leading development teams and collaborating with client SMEs.
Knowledge of software configuration management systems.
Strong client interfacing and communication skills.
Project and team management experience.
Preferred Skills
Domain expertise in Life Sciences – Clinical Trials and Compliance & Safety.
Experience in regulated environments requiring validation and documentation standards.
Strong analytical mindset with ability to align business processes with technology solutions.
Why Apply?
This opportunity is ideal for experienced Life Sciences IT professionals seeking strategic roles in regulatory technology, clinical systems implementation, and digital transformation initiatives. The role offers exposure to global clients and high-impact regulatory projects.
Apply now through ThePharmaDaily.com to advance your career in Regulatory Technology, Clinical Systems, and Life Sciences Business Analysis.
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