Judith Ann Sabu

About Judith Ann Sabu

Regulatory Affairs Analyst with 2 years of experience in Regulatory Affairs domain (Medical device-Combination Products). MEDICAL DEVICES RA • Experience working with combination products (PFS, Auto injector, Pre filled pen, Reusable pens etc.) •Supported in EU MDR transition activities. •Hands on experience in regulatory submission on Standalone medical device and combination biological products (Drug Device) for the developed markets (Europe as per MDD and EU MDR, USFDA, Health Canada and other global regulatory bodies. •Good knowledge in global standards and regulatory requirements (EU MDR/ US FDA and other regulatory markets) for medical devices. •Collection and archival of source documents for regulatory submission. •Notified Body Opinion (NBO) submission for Europe. •Support for query responses from different Regulatory agencies. •Maintenance of change control and CAPA details. •Support in LCM activities. •Experience in the basic roles and responsibilities of regulatory affairs department. •Assistance in Scientific advice package, Paediatric investigation plan package and dossier sections, formatting for submission, archival of SAE\'s, update regulatory submission trackers and Regulatory Intelligence. •Introductory knowledge on ICH guidelines •Timely update of stability data for annual report submission to FDA. •Prepared template for CTD modules 2, 3 and 4. •QC check on documents for submission. •Regulatory Intelligence •Understand the basic requirements for compilation, validation, publishing and submission of annual report in Lorenz docuBridge via ESGY portal. •Observed and participated in the submission of PIP via IRIS.

Experience

1. Regulatory Affairs Analyst

   Biocon

   Nov 2021 — Present · Bengaluru, IN

   Medical Devices Regulatory Affairs

Education

• St. Berchmans College

  Bachelor's degree, Biotechnology and Botany, Distinction

  2016 — 2019

• Kristu Jayanti College Autonomous

  Master's degree, Biotechnology, Distinction

  2019 — 2021