Overview
Regulatory Business Analyst Jobs in United States at Largeton Group
Title: Regulatory Business Analyst
Company: Largeton Group
Location: United States
Regulatory Business Analyst- regulatory operation and digital innovation
Location: Remote
Pharma*
Duration: 1 year+
EST CANDIDATES ONLY
Linkedin must
We are seeking a Business Analyst to join the Regulatory Operations and Digital Innovation team within the Global Regulatory Affairs (GRA) division of our pharmaceutical client. This individual will play a critical role in supporting digital transformation initiatives, serving as the liaison between business stakeholders and technical teams to ensure that platforms, systems, and tools align with the evolving needs of Regulatory Affairs professionals.
This Position Requires Strong Agile Experience (e.g., Backlog Grooming, User Story Development, Sprint Planning) And Ideally Experience In Regulatory Operations, Such As
Health Authority Engagement
Regulatory Submissions Management
Publishing
Labeling
Regulatory Information Management (RIM)
The ideal candidate will thrive in a fast-paced, matrixed environment and bring both functional expertise and technical acumen to the role.
Key Responsibilities
Gather, analyze, and document business and functional requirements in close partnership with Regulatory Affairs stakeholders and IT teams
Write clear, testable user stories, define acceptance criteria, and manage the product backlog in Agile environments
Facilitate Agile ceremonies such as backlog grooming, sprint planning, and retrospectives
Develop process flows, functional specifications, and traceability matrices to ensure full alignment between requirements and deliverables
Collaborate with QA, developers, and users during UAT, validating business needs are met and identifying defects or gaps
Assist in data migration, system configuration, and change management as part of platform implementations
Support ongoing enhancements to Regulatory platforms and tools by gathering feedback, assessing change requests, and helping prioritize feature development
Ensure that all work is compliant with regulatory standards
Qualifications
5–10 years of experience as a Business Analyst in the pharmaceutical, life sciences, or healthcare domain, ideally supporting Regulatory Affairs functions
Hands-on experience working in Agile/Scrum environments, with proven ability to translate business needs into technical requirements and user stories
Familiarity with regulatory business processes and systems including health authority correspondence, regulatory submission tracking, labeling, and publishing
Experience with platforms such as Veeva Vault RIM is highly desirable
Proficient in using tools such as JIRA, Confluence, Azure DevOps, Visio etc.
Strong understanding of data integrity, compliance, validation, and SDLC documentation
Excellent communication, facilitation, and stakeholder management skills
