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Confluence
Regulatory Affairs
Regulatory Compliance
Product owner

Summary

Position: Technical Product Owner

Mode of Employment: C2H OR FTE

Location: Raritan/NJ (Onsite)

JD:

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.

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: 80127832
Position Id: 9041125
Posted 10 hours ago

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Technical Product Owner

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Technical Product Owner

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