Regulatory Affairs Systems Lead

TPO - Regulatory

• Act as Technical 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.
• 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.