Arundhati Ghosh

Arundhati Ghosh has extensive experience in regulatory affairs across various organizations. At AstraZeneca, Arundhati served as Associate Director of Regulatory Affairs, leading the regulatory strategy for a Type B PIND FDA interaction and managing the first AZ pilot EU CTR submission for a Phase 2 program. In the role of Regulatory Affairs Manager, Arundhati oversaw submissions for multiple Phase 1/2 programs. As Director of Regulatory Affairs at ERYTECH Pharma, Arundhati led the delivery of BLA submission documents for a first BLA filing. Earlier positions include Regulatory Affairs Scientist/Project Manager at RareMoon, where Arundhati managed orphan drug designations, and Regulatory Affairs Specialist at Technical Resources International, Inc., preparing INDs and safety reports. Arundhati began a career in regulatory affairs with a focus on orphan drug designations and regulatory compliance, supported by academic achievements including a BSc in Biotechnology and a PhD in Microbiology from King's College London.