Sunita S.

About Sunita S.

Experienced and highly knowledgeable scientist with a PhD in Human Genetics and an MPH, with demonstrated expertise in public health, regulatory science, biomedicine, and pharmacogenetics. Skills and experience include the following-Adept at independently conceptualizing, developing, and leading complex research studies to investigate emergent issues and development of innovative recommendations and conclusions to long-standing health-related issues-Involved in collaborating with strong teams across multiple areas of bench-level science, including both internal and external collaborators and regulatory bodies, such as FDA-Participation in grant writing, evaluation / coordination, reporting criteria, and policy efforts related to in vitro toxicity testing and medical devices-Excellent leadership and guidance related to the review of scientific data-Exceptional written and verbal communication skills with robust publication and scientific presentation history catered toward scientific and medical communities-Proven technical expertise for high throughput screening, medical devices and in vitro diagnostics-Deadline-driven review of scientific data and regulatory action in support of medical device and in vitro diagnostic submissions for approval or disapproval, where appropriate.Specialties: Scientific Research, Public Health, Human Genetics, Pharmacogenetics, Biotechnology, Biomedicine, Assay Validation, High Throughput Screening, Toxicology, Quality Control, In Vitro Testing, Multidisciplinary Research, Scientific Presentations & Publications, Data Analysis, Results Analysis, Disease Prevention & Treatment, Communication, Policy Analysis / Review, Academic & Corporate Collaboration, Laboratory Testing, Training & Mentoring, Regulatory Affairs/Devices and In Vitro Diagnostics

Experience

1. Associate Director for Regulatory Science, Cder Office of New Drugs Office of Infectious Diseases

   FDA

   Mar 2019 — Present

Education

• University of Chicago

  Doctor of Philosophy (Ph.D.), Human Genetics

  2002 — 2007

• Saint Louis University

  Master of Public Health (MPH), Epidemiology/Environmental Occupational Health

  1999 — 2001

• Lake Forest Academy

  Diploma

  1991 — 1995

• Saint Louis University

  B.A., English/Biology

  1995 — 1999