Business Analyst

About Us:Birlasoft, a global leader at the forefront of Cloud, AI, and Digital technologies, seamlessly blends domain expertise with enterprise solutions. The company’s consultative and design-thinking approach empowers societies worldwide, enhancing the efficiency and productivity of businesses. As part of the multibillion-dollar diversified CKA Birla Group, Birlasoft with its 12,000+ professionals, is committed to continuing the Group’s 170-year heritage of building sustainable communities.Yrs of exp- 12 -15 yrsLocation- NoidaImmediate joinersAct as Technical Product Owner for global regulatory systems and solutions, ensuring alignment with business goals and compliance requirements.Gather, analyze, and document business requirements from regulatory stakeholders across global regions, ensuring clarity and completeness.Should be from Pharma domain only.Manage product backlogs in JIRA, defining clear user stories, acceptance criteria, and prioritization based on business value.Collaborate with development, QA, and regulatory teams to ensure product features meet both technical specifications and regulatory standards.Facilitate workshops, requirement-gathering sessions, and backlog grooming using Confluence for documentation and collaboration.Drive solution design discussions, ensuring integration with existing regulatory and submission management platforms.Oversee end-to-end delivery of regulatory systems enhancements, including planning, testing, validation, and deployment.Ensure adherence to pharmaceutical regulatory frameworks (e.g., FDA, EMA, ICH) and compliance with data integrity and GxP standards.Partner with IT, quality, and compliance teams to manage change control and validation activities for regulated systems.Provide thought leadership on digital tools and process optimization in the global regulatory affairs space.Support User Acceptance Testing (UAT) by developing test scenarios, coordinating execution with business users, and validating results against requirements.Track, triage, and resolve defects identified during UAT, working closely with developers and testers to ensure timely fixes.Participate in and lead daily Scrum stand-ups, sprint planning, reviews, and retrospectives to ensure team alignment and delivery velocity.