Gauri Swarup

About Gauri Swarup

Adaptable Regulatory Affairs graduate student with a solid scientific background and a…

Experience

1. Regulatory Affairs Specialist

   Weill Cornell Medicine

   Dec 2024 — Present · New York, NY, US

   Managed regulatory activities for 25+ clinical trials (Phase ensuring compliance with ICH-GCP, FDA, OHRP, and HIPAA. Optimized workflows, expedited approvals, minimized protocol deviations, and ensured audit Oversaw investigator- and sponsor-initiated studies, including observational and interventional trials with major biopharmaceutical companies, ensuring all regulatory submissions met IRB (CIRB Advarra), FDA, and sponsor requirements.• Led the preparation and submission of IND applications, FDA forms (1572, 3455, 3674), SAE reports, and Protocol Deviation reports, ensuring timely regulatory approvals, strict compliance, and minimizing study delays, thereby driving seamless trial progression• Managed IRB submissions and approvals for committees (PRMC, RSC, DSMBs, CIRB Advarra), ensuring regulatory compliance, identifying potential delays, and expediting the review process to facilitate on-time initiation for 25+ studies.• Maintained regulatory documentation (Investigator site Files, DOA logs, CTMS records), achieving 100% audit readiness and reducing compliance risks by 30%.• Coordinated and streamlined site visits like SQV(Site Qualification), SIV(Site Initiation), routine monitoring, close-outs) for 15+ sites, identifying gaps in patient recruitment, data collection, and regulatory compliance, and implementing corrective actions to ensure smooth trial progression and adherence to timelines.• Proficient in regulatory systems (OnCore, Complion, ComplianceWire), streamlining submissions and reducing processing time by 25%.• Created and maintained regulatory trackers in Excel to monitor submission progress, CITI GCP training expirations, and CV updates, study expiration for multiple studies, ensuring 100% on-time renewals and reducing delays by 20% in study progress.

Education

• Delhi Public School - R. K. Puram

  student, Science, Biology

• Northeastern University

  Master's degree, Drug Regulatory Affairs

• SRM IST Chennai

  Bachelor's degree, Genetics

  2016 — 2020