Priyanka Thapliyal

• Lead global regulatory submissions including MAAs, NDAs, BLAs, renewals, and post-approval variations across EU, US, APAC, and ROW regions.
• Drive CMC strategy and submission planning for complex MRP and DCP procedures - ensuring timely, compliant submissions and lifecycle continuity.
• Collaborate with cross-functional teams and regional affiliates to ensure submission readiness, alignment, and on-time delivery.
• Design and implement submission strategies leveraging regulatory intelligence, global guidelines, and country-specific requirements for APAC markets (e.g., Singapore, Australia, Thailand, Vietnam).
• Support Health Authority engagement, including EMA, FDA, and APAC agencies through preparation of meeting packages, briefing documents, and post-submission responses.
• Collaborate on IDMP implementation and Veeva Vault RIM optimization - enabling structured CMC data management, traceability, and data quality across product portfolios.
• Drive continuous improvement initiatives in submission workflows and data management systems to enhance regulatory efficiency.
• Mentor new team members and deliver regulatory intelligence sessions to strengthen team awareness on global CMC and variation filing requirements.

KEY ACHIEVEMENTS

• Spearheaded CMC data harmonization for multiple market submissions, improving efficiency and reducing review cycle times.
• Drove successful alignment sessions for simultaneous EU & APAC product renewals, streamlining dossier updates and approval tracking.

• Managed Master Document control (SOPs, validation protocols, SMFs) and supported CMC compliance during regulatory inspections.
• Oversaw APQR compilation and documentation review per USFDA and internal quality systems.
• Coordinated data integrity reviews and documentation support during USFDA and site audits, achieving zero major observations.
• Utilized LIMS for control sample traceability and documentation management within GMP frameworks.