Arundhati Ghosh

About Arundhati Ghosh

Versatile regulatory affairs (RA) professional with over 10+ years of RA experience in managing both early & late program (NDA/IND/CTA) submissions involving small molecules, peptides and large biologics in a highly matrixed cross-functional environment. Lead author/project lead for multiple successful FDA/EMA approvals for Orphan Drug Designations (ODD). Has excellent organizational, time-management and oral/written communication skills and is able to simultaneously work on multiple projects with accelerated timelines, while leading internal and external shareholders through complex drug development projects within a highly x-functional and matrixed environment. Core competencies:• Associate Regulatory Affairs Dir. within the Cardiovascular/Renal/Metabolic Diseases therapeutic areas for both small molecules and biologics• Regulatory strategic expertise for orphan drug development• Manages/leads submission portfolio of Phase 1-3 clinical trials • Has experience with rare disease orphan applications (ODDs)• Research experience in Cell signaling, Signal transduction/pathways, Receptor/ligand interactions• Excellent scientific/technical writing, time management and communication skills• US RAC Certified (RAPS 2019)

Experience

1. Associate Director of Regulatory Affairs

   AstraZeneca

   Jan 2020 — Present · Gaithersburg, MD, US

   US lead responsible for delivering an NDA submission/developing the regulatory strategy for a Type B PIND FDA interaction for a NME based on clinical and non-clinical issues •Co-lead responsible for reg submission strategy for a complex Ph2/3 IND/CTA program including HA responses for US/Canada and RoW submissions•Lead early team as a US Regulatory strategic lead/US Agent responsible for T1D ODD for a new biologic •US lead and agent for an established product within the CVRM (established brand portfolio) • Lead, responsible for multiple INDs/CTAs submissions including conducting project K/O meetings, defining submission requirements while negotiating timelines with external and internal x-functional team• Prepared & lead the PIP K/O strategy and submission meeting (along with the RAD) providing previous regulatory precedence for a successful full PIP waiver for CKD.• Lead cross-functional weekly team meetings, determined submission risks, planned mitigation strategies, • Lead/authored NDA/IND/CTA submission documents and achieved timely global submissions• Lead between AZ x-functional teams and CROs for multiple Ph1-Ph3 global CTA rollout submissions, including managing day-to-day regulatory activities for multiple investigational products• Managed the organization, preparation and reviews of IND/CTA submissions & amendments, DSURs, annual reports, IBs, safety reports, scientific advice, PIPs and ODDs being accountable for their completeness, accuracy, issues, & helped to ensure compliance with U.S. & foreign regulatory agency requirements • Lead regulatory defense cross-functional team discussions to HAQs • Performed reviews of CSPs & CSRs to focus attention on deficient/missing items and provided justifications/explanations for the changes to align with regulatory needs

Education

• Keck Graduate Institute

  PPM (Postdoctoral Professional Masters), Bioscience Management

  2013 — 2014

• King's College London

  BSc, Biotechnology

  1994 — 1997

• King's College London

  PhD, Microbiology

  1997 — 2002

Skills

• Emsa
• Ctas
• Cell Based Assays
• Molecular Genetics
• Gel Electrophoresis
• Pcr
• Microbiology
• Clinical Protocol Reviews
• Uv-Vis
• U.s. Food and Drug Administration (Fda)
• Sharepoint
• Qpcr
• Drug Discovery
• Research
• Site-Directed Mutagenesis
• Mutagenesis
• Cross-Cultural Communication Skills
• Bacterial Transformation
• Cell
• Cancer
• Regulatory Affairs
• Lifesciences
• Purification
• Protein Expression
• Orphan Drugs
• Cell Culture
• Molecular Biology
• Cell Signaling
• Clinical Trials
• Elisa
• Genetics
• Proteomics
• Good Clinical Practice (Gcp)
• Immunoprecipitation
• Life Sciences
• Tissue Culture
• Sds-Page
• Immunoassays
• Electrophoresis
• Oncology