Hema Balasubramanian

JERSEY CITY, NJ Hema Balasubramanian ASSOCIATE PRINCIPAL CONSULTANT, REGULATORY AFFAIRS

Hema has more than 19 years of experience in drug, biologic, and gene therapy development with a focus on Regulatory Affairs and Regulatory Chemistry, Manufacturing, and Controls (CMC) development. She has extensive regulatory experience in the field of infectious disease, oncology, immuno-oncology, autoimmune, and various rare diseases and with the development of novel biologics that include peptides, monoclonal antibodies (mAbs), fusion mAbs, oligonucleotides, novel siRNA, and novel vaccines. At Halloran, Hema provides regulatory support for product development programs ranging from early-stage to late-stage development. She is skilled in developing Regulatory CMC and global regulatory strategies, including those for the US FDA, BfARm, Health Canada, and TGA-Australia. This includes preparing documentation for and attending agency meetings, preparing IND/CTA/CTN/IMPD submissions and amendments, safety reporting, and special designations. 

Before joining Halloran, Hema was with Biocon Limited where she was responsible for the regulatory strategies and program management for INDs and IMPDs for early-phase clinical development of both in-house and partnered novel biologics in the US/EU/Australia/Canada. Before her time at Biocon, Hema was at Protein Design Labs (PDL) as part of their protein chemistry team. During her time there she developed the characterization assays for PDL’s monoclonal antibodies (Peptide Mass Fingerprinting, Sequencing by LC-MS/MS, Glycan Analysis, Charge Variant Analysis, Western Blotting, SDS-PAGE) and established the primary sequence for multiple mAb products.

Education:

San Jose State University, CA, Master of Science, Chemistry
Regulatory Affairs Certification (RAC)