PRINCIPAL CONSULTANT

Area(s) of responsibility

• 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.