Ravikumar Tailor

• Supported UK QPPV with day-to-day PV responsibilities and acted as backup during unavailability for more than 15 Clients.
• Maintained oversight of the safety profile for multiple MAH portfolios, including review of PSURs, RMPs, signal reports, and risk minimization activities.
• Coordinated timely regulatory submissions and safety updates in line with MHRA and EU GVP requirements.
• Monitored PV system performance through compliance metrics and initiated quality improvement strategies.
• Led MHRA inspection preparation, served as inspection lead, and managed post-inspection CAPAs.
• Delivered regulatory intelligence updates on monthly basis.
• Acted as inspection lead for MHRA Inspection and client audits; coordinated CAPA planning and implementation.

Key Achievements

• Built strong partnerships with stakeholders for mutual benefit.
• Successfully deputized UK QPPV during MHRA interactions and regulatory inspections.
• Implemented a risk-based compliance framework that enhanced QPPV oversight and inspection readiness.
• Played a key role in adapting the PV system to meet Windsor Framework and Brexit-related regulatory changes.

• Acted as primary liaison between UK affiliate, global PV team, and MHRA.
• Managed PSUR/RMP submissions and supported signal and variation tracking.
• Led RA and PV support for generics regulatory lifecycle activities, while mentoring and managing key projects independently. Maintained accurate regulatory databases and ensured XEVMPD compliance.
• Ensured compliance post-Brexit through risk assessment and Planning.

Key Achievements

• Successfully led PV inspection activities and enhanced RA/PV documentation standards.
• Promoted ahead of cycle due to leadership in regulatory submissions and compliance support.

• Managed regulatory lifecycle activities (renewals, variations) and PV obligations for more than 100 MAs.

• Supported end-to-end PV compliance and RA lifecycle management for generics more than 30 MAs.
• Acted as PV contact for outsourced QPPV and coordinated safety submissions and PSMF maintenance.
• Served as person responsible for all in-house PV activities.

Key Achievements

• Played a central role in MAH (GxP) inspections and RA-PV system updates.