Christine Berardi
Director, Global Regulatory Strategy
- Role
- Director, Global Regulatory Strategy at AbbVie
- Location
- Philadelphia, PA, US
- LinkedIn followers
- 500 followers
About Christine Berardi
A regulatory affairs specialist with scientific background with drug development experience for both small and large molecules from identification of lead compound through Phase 2 clinical trials, and late stage and commercial activities. Expertise spans CMC development and optimization, GxP quality support, Phase 1 clinical trial management, early and mid-stage FDA and Canadian regulatory strategy and late stage EMA regulatory strategy, with a focus on regulatory communications including electronic regulatory filings and written and face to face Agency meeting support.
Experience
Director, Global Regulatory Strategy
Feb 2022 — Present
Education
Jefferson Health
PhD, Biochemistry and Molecular Biology
2004 — 2008
Center for Professional Innovation and Education (CfPIE)
Pharmaceutical Development Certified Professional (PDCP)
Lebanon Valley College
BS, Biochemistry and Molecular Biology
2000 — 2004
Skills
- Molecular Biology
- Biochemistry
- Protein Chemistry
- Protein Expression
- Protein Purification
- Drug Development
- Regulatory Affairs
- Chemistry
- Fda
- Biotechnology
- Cell Biology
- Biophysics
- Laboratory
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