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Technical Product Owner/ BA - Hybrid

The Dignify Solutions, LLC

Raritan, NJ

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JOB DETAILS
SKILLS
Acceptance Testing, Agile Programming Methodologies, Atlassian JIRA, Biotech and Pharmaceutical, Bug Tracking/Defect Management, Business Analysis, Change Control, Change Management, Data Quality, Documentation, Establish Priorities, FDA (Food and Drug Administration), GxP, ICH Regulations, Maintain Compliance, Process Improvement, Product Backlog, Product Management, Quality Assurance, Regulations, Regulatory Compliance, Regulatory Requirements, Regulatory Submissions, Requirements Management, Requirements Validation/Verification, Scrum Project Management and Software Development, Sprint Planning, Standup Meetings, System Validation, Test Plan/Schedule, Test Scenario, Thought Leadership, Time Management, Validation Testing
LOCATION
Raritan, NJ
POSTED
30+ days ago
JD -
  • Act as Technical Product Owner, BA for global regulatory systems and solutions, ensuring alignment with business goals and compliance requirements.
  • Gather, analyze, and document business requirements from regulatory stakeholders across global regions, ensuring clarity and completeness.
  • Manage product backlogs in JIRA, defining clear user stories, acceptance criteria, and prioritization based on business value.
  • Collaborate with development, QA, and regulatory teams to ensure product features meet both technical specifications and regulatory standards.
  • Facilitate workshops, requirement-gathering sessions, and backlog grooming using Confluence for documentation and collaboration.
  • Drive solution design discussions, ensuring integration with existing regulatory and submission management platforms.
  • Oversee end-to-end delivery of regulatory systems enhancements, including planning, testing, validation, and deployment.
  • Ensure adherence to pharmaceutical regulatory frameworks (e.g., FDA, EMA, ICH) and compliance with data integrity and GxP standards.
  • Partner with IT, quality, and compliance teams to manage change control and validation activities for regulated systems.
  • Provide thought leadership on digital tools and process optimization in the global regulatory affairs space.
    Support User Acceptance Testing (UAT) by developing test scenarios, coordinating execution with business users, and validating results against requirements.
  • Track, triage, and resolve defects identified during UAT, working closely with developers and testers to ensure timely fixes.
  • Participate in and lead daily Scrum stand-ups, sprint planning, reviews, and retrospectives to ensure team alignment and delivery velocity.

About the Company

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The Dignify Solutions, LLC