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Danielle Smith Location
Melbourne, VIC, AU
Danielle Smith Work
Vice President and Global Head of Regulatory Affairs @ (August 2025 - Present)
Senior Director and Global Head of Regulatory Affairs @ (May 2019 - August 2025)
Associate Director and Program Manager and Regulatory Affairs Manager - Moxidectin Onchocerciasis NDA @ (August 2016 - May 2019)
Principal Development Manager @ (July 2012 - August 2016)
Senior Development Manager @ (August 2010 - July 2012)
Project Manager @ (August 2008 - August 2010)
Research Fellow - ARC Centre of Excellence in Structural and Functional Microbial Genomics @ (September 2004 - August 2008)
ARC Research Fellow - Department of Biochemistry @ (March 2003 - September 2004)
Medical Laboratory Scientist @ (November 1997 - March 2003)
Danielle Smith Education
Monash University
BSc(Hons) (Pathology & Immunology)
University of Melbourne
PhD (Microbiology & Immunology)
Danielle Smith Skills
Writing
Development
Clinical Trials
Stakeholder Management
Independent Thinking
Cell Biology
Western Blotting
Medical Ethics
Animal Models
Infectious Diseases
Clinical Research
Grants
Biotechnology
Cell
Communication Skills
Regulatory Affairs
Immunology
Virology
Life Sciences
Team Management
Cell Culture
Cmc Management
Strategic Planning
Drug Discovery
Molecular Biology
Clinical Trial Management
Research Ethics
Lifesciences
GCP
Drug Development
Clinical Development
Collaboration
u.s. Food and Drug Administration Fda
MS Project
Cell Based Assays
Microbiology
Vaccines
Cancer
Orphan Drugs
Management
Documentation
Project Management
Product Development
Research
Biochemistry
Science
Pharmaceutical Industry
Technology Transfer
Flow Cytometry
GLP
Cytokines
R&d
Sop
Commercialization
Biopharmaceuticals
New Drug Application Nda
Regulatory Filings
Health Equity
Regulatory Approvals
u.s. Food and Drug Administration
New Drug Application
Danielle Smith Summary
Danielle Smith, based in Melbourne, VIC, AU, is currently a Vice President and Global Head of Regulatory Affairs at Medicines Development for Global Health. Danielle Smith brings experience from previous roles at Medicines Development for Global Health. Danielle Smith holds a BSc(Hons) in Pathology & Immunology @ Monash University. With a robust skill set that includes Writing, Development, Clinical Trials, Stakeholder Management, Independent Thinking and more. Danielle Smith has 1 emails on RocketReach.
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