Sowmya Raju

Sowmya is a Regulatory Affairs professional with over 15 years’ experience in training teams (onsite and offshore) and gathering requirements. She excels in providing SME support, managing data optimization, and overseeing variation management projects for xEVMPD submissions.

With a strong background in project management, Sowmya strategically contributes to various roles and ensures successful project execution. As a validation lead in Computer System Validation (CSV), she ensures compliance in both pre- and post-approval regulatory data management.

Her expertise includes IDMP assessments, gap analysis, and data mapping, driving efficiency and regulatory adherence throughout the product lifecycle.