Nitisha Deguire
Global Regulatory Affairs
- Role
- Director Global Regulatory Affairs at Biontech Us at BioNTech SE
- Location
- Washington, DC, US
- LinkedIn followers
- 500 followers
About Nitisha Deguire
Nitisha’s expertise encompasses strategic support for the development of biological, biotechnological, and biosimilar products during preclinical development and throughout the different phases of development. Nitisha has over 15 years of experience in regulatory affairs, biomedical research, biotechnology, clinical studies and biologics consulting services. Her expertise includes new technologies, virology, molecular biology, immunology (including immunogenicity), vaccines, due diligence, audits and global regulatory affairs. With her scientific background and experience working on a range of products for the pharmaceutical industry, Nitisha\'s expertise on FDA, EMA and global regulatory affairs requirements has allowed products to progress rapidly through development.Her expertise includes:• Developing innovative regulatory strategies. Leading large matrix teams for the successful strategic planning, preparation and submission of Investigational Drug Applications (INDs)/ Clinical Trial Applications (CTAs) and Biologics License Applications (BLAs)/ Marketing authorization applications• Deep knowledge of drug development (various therapeutic areas including vaccines and oncology) from early phases to late phases • Critical input on CMC, Nonclinical and Clinical strategy• Problem solving skills, eye for process improvement and innovative, entrepreneurial mindset• Leading the preparation of health authority meeting documents and lead health authority meetings with global health authorities.• Point of contact with regulatory agencies (FDA) Nitisha’s experience covers combination products, therapeutic proteins and peptides including monoclonal antibodies, oncology products and protein/mRNA based vaccines.
Experience
Director Global Regulatory Affairs at Biontech Us
Jan 2025 — Present · US
Education
University of Westminster
Master of Science (MSc), Medical Molecular Biology
2010 — 2011
University of Lausanne
Doctor of Philosophy (Ph.D.) in Microbiology, HIV, antiviral immunity
2012 — 2015
University of Strasbourg
Bachelor of Science (BSc), Biochimie Biologie Moléculaire
2004 — 2008
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