Job Description

About the Role: -
We are seeking an experienced Senior Business Analyst. The ideal candidate will have solid business analysis expertise combined with a solid understanding of Regulatory Affairs processes and Regulatory Information Management (RIM) systems. The Business Analyst will work closely with business stakeholders, SMEs, IT teams, implementation partners, and testing teams to ensure business requirements are accurately captured, documented, implemented, and validated. The role requires strong analytical, communication, stakeholder management, and SDLC experience in a regulated pharmaceutical environment.
Key Responsibilities:-
• Lead business analysis activities for assigned workstreams.
• Elicit, analyze, document, and manage business, functional, and non-functional requirements.
• Create and maintain Business Requirements Documents (BRDs), Functional Specifications (FS), User Stories, Process Flows, Use Cases, and Traceability Matrices.
• Facilitate workshops, requirement gathering sessions, solution discussions, and stakeholder reviews.




• Ensure end-to-end traceability of requirements throughout the project lifecycle.
• Support impact assessments and requirement change management activities.
• Collaborate with business stakeholders and SMEs to understand and document Regulatory Affairs business processes.
• Support implementation of Regulatory Information Management (RIM) capabilities and associated business processes.
• Ensure business requirements are accurately interpreted and implemented by implementation partners and technical teams.
• Review and validate business process designs, workflows, and functional deliverables.
• Support alignment of requirements across multiple workstreams and business functions.
• Review business process integration points and ensure alignment across upstream and downstream systems.
• Work closely with Configuration, Integration, Migration, Data, Testing, Validation, and Change Management teams.
• Collabo

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