Product Regulatory Expert

1 week ago

Noida, Uttar Pradesh, India beBeeRegulatory Full time ₹ 1,50,00,000 - ₹ 2,10,00,000

About Birlasoft

At the intersection of domain expertise, enterprise solutions, and digital technologies, our organization converges to redefine business processes. We pride ourselves on a consultative approach, driving societal progress by enabling customers to run businesses with unmatched efficiency and innovation.

Job Responsibilities:

  • We seek an experienced Technical Product Specialist to lead global regulatory systems and solutions, ensuring alignment with business objectives and compliance requirements.
  • The ideal candidate will gather, analyze, and document business requirements from regulatory stakeholders across global regions, ensuring clarity and completeness.
  • He/She must manage product backlogs in JIRA, defining clear user stories, acceptance criteria, and prioritization based on business value.
  • This role requires collaboration with development, QA, and regulatory teams to ensure product features meet both technical specifications and regulatory standards.
  • As a Technical Product Specialist, you will facilitate workshops, requirement-gathering sessions, and backlog grooming using Confluence for documentation and collaboration.
  • You will drive solution design discussions, ensuring integration with existing regulatory and submission management platforms.
  • Key responsibilities include overseeing end-to-end delivery of regulatory systems enhancements, including planning, testing, validation, and deployment.
  • Ensuring adherence to pharmaceutical regulatory frameworks (e.g., FDA, EMA, ICH) and compliance with data integrity and GxP standards is crucial.
  • You will partner with IT, quality, and compliance teams to manage change control and validation activities for regulated systems.
  • This position requires thought leadership on digital tools and process optimization in the global regulatory affairs space.
  • Support User Acceptance Testing 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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