Senior Business Analyst - Pharmaceutical

Job Description

About the Role: -

We are seeking an experienced Senior Business Analyst. The ideal candidate will have strong 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.
• Collaborate with vendors and implementation partners to clarify requirements and resolve functional issues.
• Identify dependencies, risks, assumptions, and issues impacting project delivery.
• Support workstream leads in planning and coordinating project activities.
• Support preparation and review of test scenarios, test scripts, and validation documentation.
• Ensure business requirements are adequately covered in System Integration Testing (SIT), User Acceptance Testing (UAT), Operational Qualification (OQ), and Performance Qualification (PQ).
• Review test data and ensure business scenarios are traceable to approved requirements.
• Participate in testing activities, defect triage, root cause analysis, retesting, and issue resolution.
• Support business teams during UAT and validation cycles.
• Support data-related assessments and business validation activities where required.
• Collaborate with business SMEs and data owners to validate business rules, mappings, reconciliations, and data quality requirements.
• Participate in data validation, business reviews, and readiness activities supporting program delivery.
• Ensure compliance with established SDLC processes, governance frameworks, SOPs, templates, and quality standards.
• Ensure all business analysis deliverables are completed with high quality and within agreed timelines.
• Support audit, inspection, validation, and compliance activities as required.
• Requirements :-
• 8+ years of Business Analysis experience in the pharmaceutical, life sciences, or regulated industry.
• Proven experience supporting enterprise application implementations.
• Strong experience with requirements elicitation, business process analysis, stakeholder management, and testing support.
• Experience working within Agile, Waterfall, or hybrid delivery models.
• Experience across the Software Development Lifecycle (SDLC).
• Strong understanding of Regulatory Affairs processes.
• Good understanding of Regulatory Information Management (RIM) concepts and business operations.
• Experience working with cross-functional business and IT teams.
• Ability to translate complex business requirements into functional requirements and actionable deliverables.