Debashish Bhattacharya

Associate Director Regulatory Affairs (Cmc) @Ultragenyx

CA, US

Spearheaded the CMC regulatory strategy for multiple complex drug development programs, leading to the successful approval of 1 mRNA and 1 mAb CMC dossier (CTA). Oversaw the preparation, submission, and lifecycle management of all CMC sections of regulatory dossiers (IND and MAA) to global health authorities (FDA, EMA, etc.). Collaborated cross-functionally with R&D, Quality Assurance, Manufacturing, and external stakeholders to ensure alignment with regulatory requirements and timely submissions.