Nandini Banerjee

About Nandini Banerjee

Regulatory Affairs professional with 4+ years of experience in U.S. FDA regulations, specializing in CMC submissions, labeling, and post-approval changes.1.5 years of research experience. Skilled in eCTD, CMC reviews, change control assessments and pharmacovigilance (PV) coordination. Adept at collaborating cross-functionally with quality, manufacturing and PV teams to drive regulatory success.

Experience

1. Regulatory Affairs Associate

   BIONPHARMA, INC.

   Sep 2023 — Present · Princeton, NJ, US

   Manage end to end CMC lifecycle submissions for U.S. FDA for various post approval changes including drug product site transfers, addition of alternate API source, analytical sites, packagers etc- Review technical data packages, DMFs for dossier preparation, identify gaps or risks, and collaborate with stakeholders to resolve issues- Assess change controls for proposed manufacturing changes and determine regulatory strategies that support change implementation- Collaborate with internal teams, CMOs, and external stakeholders to align on regulatory strategies and meet objectives- Coordinate and pharmacovigilance activities between company and PV service provider to ensure compliance with reporting and safety obligations- Prepare and organize documentation for PV audits and inspection, ensuring timely, accurate, and comprehensive responses to auditor/FDA inspector’s document requests.

Education

• Department of Microbiology, Savitribai Phule Pune University

  M.Sc., Microbiology

  2015 — 2017

• Mithibai College

  B.Sc., Microbiology

  2012 — 2015

• Northeastern University

  Master's degree, Regulatory Affairs