Business Analyst _Pharma Regulatory
Business Analyst _Pharma Regulatory
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Job Description
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.
Employment Type
Full-time
