Technical Product Owner

4 weeks ago

Bengaluru Karnataka India, Karnataka Mount Talent Consulting Pvt Ltd. Full time

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.

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