Amrita Modak

Led CTA/IND submission post-approval activities and managed EU and US submissions for cell and gene therapy oncology programs for Miltenyi Biotech. Managed HAQ and RFI responses and drove regulatory strategy for client in-house clinical studies and medical device IVDR studies.

Owned CTA/IND submissions for EU and US clinical trials, including HAQ and RFI coordination, ensuring timely and compliant delivery. Prepared EU CTR (Regulation 536/2014) and executed submission components across IND/NDA/BLA/S-BLA, DSUR/SUSAR and post-approval lifecycle (PBRER and CMC/non-CMC variations).

Managed CTA submissions across EEA, ROW, and Health Canada, covering initial/new-file submissions and substantial amendments through to CSR and EOT notifications. Prepared EU CTR (Regulation 536/2014) components for in-house and CRO-led studies and supported IND filings and EU IVDR/MDR compliance for diagnostic and medical device activities.

Prepared initial CTA submission packages for European countries (e.g., Belgium and Ireland via CESP) and assembled EC submission components including site suitability, PI documents and GCP certificates. Managed notification and EOT packages across multiple countries and ensured QC review timing and compliant eTMF/InfoStart documentation for EU CTIS processes.

Activities and societies: M.Sc. dissertation: “Isolation of genomic DNA from different kinds of bio specimen (blood, bone, saliva, teeth swab) & DNA fingerprinting by STR Analysis” under Dr. A.K. Sharma (CFSL Kolkata).

Completed an M.Sc. in Biotechnology at Jadavpur University (2012), including an M.Sc. dissertation in forensic genomics and DNA fingerprinting.

Completed a B.Sc. in Biochemistry at the University of Calcutta (2010).