Jen Avenatti
- Role
- Sr Associate Director, Cmc Regulatory Affairs Biologics at Boehringer Ingelheim
- Location
- Bloomington, IN, US
- LinkedIn followers
- 500 followers
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About Jen Avenatti
A Regulatory Affairs (RA) professional with 20 years of experience in the pharmaceutical…
Experience
Sr Associate Director, Cmc Regulatory Affairs Biologics
Sep 2023 — Present
Education
Indiana University Bloomington
B.S., Environmental Science
1998 — 2003
San Diego State University
M.S., Regulatory Affairs
2005 — 2012
Skills
- Validation
- Sop
- Trackwise
- Gmp
- Capa
- Ectd
- Fda
- Generic Programming
- Regulatory Affairs
- Root Cause Analysis
- Regulatory Requirements
- Quality Assurance
- Pharmaceutical Industry
- Biotechnology
- Computer System Validation
- V&V
- Regulatory Submissions
- Change Control
- Glp
- Quality System
- Aseptic Processing
- 21 Cfr Part 11
- Clinical Trials
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