Act as Product Owner 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.
Comfortable to work with business users, PM, vendors and Sr. leadership
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.
Numbers & Facts
Location
Raritan, NJ
Skills
Acceptance Testingunmatched
Agile Programming Methodologiesunmatched
Atlassian JIRAunmatched
Biotech and Pharmaceuticalunmatched
Bug Tracking/Defect Managementunmatched
Business Analysisunmatched
Change Controlunmatched
Change Managementunmatched
Data Qualityunmatched
Documentationunmatched
Establish Prioritiesunmatched
FDA (Food and Drug Administration)unmatched
GxPunmatched
ICH Regulationsunmatched
Leadershipunmatched
Maintain Complianceunmatched
Process Improvementunmatched
Product Backlogunmatched
Product Managementunmatched
Quality Assuranceunmatched
Regulationsunmatched
Regulatory Complianceunmatched
Regulatory Requirementsunmatched
Regulatory Submissionsunmatched
Requirements Managementunmatched
Requirements Validation/Verificationunmatched
Scrum Project Management and Software Developmentunmatched
Sprint Planningunmatched
Standup Meetingsunmatched
System Validationunmatched
Test Plan/Scheduleunmatched
Test Scenariounmatched
Thought Leadershipunmatched
Time Managementunmatched
Validation Testingunmatched
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