bingi sindhoori

Managed end-to-end submission project plans for IND, CTA, MAA, NDA, BLA, lifecycle variations (CP, DCP, MRP, NP), renewals, annual reports (US, Canada, Brazil), and EAEU submissions. Led Submission Task Force coordination for complex submissions; mapped cross-functional dependencies, drove alignment, and resolved risks to protect timelines. Accountable for structured handovers to GRA Operations, ensuring Submission Managers received full planning and execution context for seamless delivery. Contribu

• Independently executed MSR dossier strategies across pharmaceutical and vaccine products in EU, APAC, LATAM, US, Canada, and ROW markets, managing multiple concurrent assignments of varying complexity. • Delivered end-to-end lifecycle submissions — EU variations (IA/IB/II), initial MAA/registrations, renewals, product expansions, site registrations, PBRER, and EAEU submissions — within agreed timelines and in compliance with regional regulatory requirements. • Coordinated site registration processes i

• Compiled Module 1 and CMC documentation for renewals, variations, and lifecycle management activities across multiple EU and emerging markets. • Coordinated with CMC, Quality, and Supply Chain teams to secure timely, compliant submission components in line with local regulatory requirements and planned timelines. • Prepared, reviewed, and tracked regulatory documents to support compliant submission execution across assigned markets. • Contributed to Periodic Quality Reviews (PQRs) and regulatory comp

• Supported preparation and compilation of Module 1 documentation for regulatory submissions across EU and emerging markets. • Assisted in lifecycle management activities including renewals and regulatory documentation updates. • Maintained regulatory documentation and ensured alignment with submission requirements. • Supported cross-functional coordination to ensure timely delivery of regulatory documents. • Gained exposure to global regulatory frameworks, submission processes, and lifecycle management in