Regulatory Business Analyst

Largeton Group; United States; Remote; USD 120,000 - 150,000; Full time

Job summary

A leading company in pharmaceutical manufacturing is seeking a Regulatory Business Analyst for their Regulatory Operations and Digital Innovation team. The candidate will support digital transformation initiatives and liaise between stakeholders and technical teams. Ideal candidates should have 5-10 years of experience in business analysis within pharma and strong Agile knowledge.

Qualifications

• Experience in pharmaceutical, life sciences, or healthcare domains.
• Hands-on experience in Agile/Scrum environments.
• Familiarity with regulatory submission tracking and publishing processes.

Responsibilities

• Gather and document business and functional requirements.
• Facilitate Agile ceremonies and manage the product backlog.
• Collaborate with QA and developers during UAT.

Skills

Agile Experience

Business Analysis

Regulatory Compliance

Stakeholder Management

Communication

Education

5–10 years of experience in Business Analysis

Tools

JIRA

Confluence

Azure DevOps

Visio

Job description

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

Seniority level

• Seniority level

  Associate

Employment type

• Employment type

  Contract

Job function

• Job function

  Research, Analyst, and Information Technology

• Industries

  Pharmaceutical Manufacturing

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