Holly Groelle
- Role
- Associate Director, Regulatory Affairs at Kyverna Therapeutics
- Location
- San Francisco, CA, US
- LinkedIn followers
- 500 followers
About Holly Groelle
Passionate regulatory professional dedicated to achieving cost-effective patient access…
Experience
Associate Director, Regulatory Affairs
Aug 2023 — Present
Direct regulatory strategy and operations to introduce cellular therapies for autoimmune disease in the clinic. Oversee clinical development in support of BLA filing. Contribute to critical thinking around study design, labeling requirements, and manufacturing to expedite delivery of cell therapies to patients.
Education
University of Maryland
B.S., Microbiology
Northeastern University
Regulatory Affairs
Dana-Farber Cancer Institute
Harvard Postdoctoral Fellow, Infectious Disease
1992 — 1994
Marine Biological Laboratory Woods Hole, MA
NIH Postdoctoral Fellow, Neuroendocrinology
1992 — 1992
Boston University School of Medicine
Ph.D., Biochemistry
Skills
- Project Management
- Gcp
- Cell Culture
- Diabetes
- Regulatory Submissions
- Pharmaceutical Industry
- Biologics
- Fda
- Oncology
- Clinical Development
- Pharmaceuticals
- Clinical Trials
- Medical Devices
- Clinical Research
- Good Clinical Practice (Gcp)
- Biochemistry
- Infectious Diseases
- U.s. Food and Drug Administration (Fda)
- Regulatory Affairs
- Pharmaceutics
- Client Relations
- Molecular Biology
- In Vitro Diagnostics
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