Business Analyst – RIM

• Job Title: Business Analyst – RIM
• Location: CA (Hybrid)
• Job Type: Contract

Job Description:

We are looking for an experienced Business Analyst with strong Regulatory Information Management (RIM) experience to support pharmaceutical regulatory and technology initiatives. The ideal candidate will have 8–10 years of Business Analysis experience, with strong hands-on experience in Pharma/Life Sciences and RIM processes, systems, and regulatory data.

• Key Responsibilities
• Gather, analyze, and document business requirements for RIM and regulatory systems.
• Work closely with Regulatory Affairs, Quality, Compliance, IT, and business stakeholders.
• Translate regulatory business needs into detailed functional requirements, user stories, and acceptance criteria.
• Analyze and improve regulatory information management processes and workflows.
• Support RIM system implementations, enhancements, integrations, and upgrades.
• Define current-state and future-state processes and identify process gaps.
• Work with stakeholders to understand regulatory data requirements, data flows, and business rules.
• Develop BRDs, FRDs, process flows, use cases, user stories, and functional specifications.
• Support data mapping, data migration, data validation, and data quality activities related to RIM.
• Coordinate with technical teams, vendors, and SMEs throughout the SDLC.
• Participate in UAT planning, test scenario development, execution, and defect validation.
• Ensure solutions align with pharmaceutical regulatory and compliance requirements.
• Support change management, training, and business readiness activities.

• Required Skills
• 8–10 years of Business Analyst experience.
• Pharmaceutical / Life Sciences experience is mandatory.
• Strong hands-on experience with Regulatory Information Management (RIM).
• Understanding of pharmaceutical regulatory processes and Regulatory Affairs.
• Experience working with regulatory data, submissions, products, registrations, and regulatory documents.
• Strong requirements gathering and stakeholder management skills.
• Experience creating BRD, FRD, User Stories, Acceptance Criteria, Use Cases, and Process Flows.
• Experience with UAT, functional testing, data validation, and defect management.
• Strong analytical, problem-solving, and communication skills.
• Ability to work effectively with business, regulatory, technology, and vendor teams.