Christina Calabrese, Ph.D.

Manager, Regulatory Affairs at Regeneron

Speaker

Christina Calabrese is a CMC Regulatory Affairs Manager at Regeneron Pharmaceuticals with a Ph.D. in Biomedical Science (Neuroscience) and over a decade of experience spanning process sciences, manufacturing support, and global regulatory strategy for biologics. She has led and supported CMC elements of INDs, IMPDs, BLAs, MAAs, and post‑approval submissions, with particular expertise in process control strategies, data interpretation, and regulatory interactions, including inspections and information request responses. Drawing on a strong technical foundation from her prior role as a Principal Process Scientist, Christina focuses on leveraging development and manufacturing data to inform risk‑based regulatory justifications and enable efficient lifecycle and future commercial submissions.