2021 -2023 Associate Director, Regulatory Affairs - Chemistry, Manufacturing and Controls (RACMC) @ Loxo at Lilly Oncology (Eli Lilly and Company)
David Paul Education
Indiana University School of Law—Indianapolis
Juris Doctorate
2006-2010
University of Arizona
Bachelor of Science (B.Sc.) (Chemistry)
1987-1991
David Paul Skills
Pharmaceutical Industry
Computer System Validation
Validation
21 CFR Part 11
Clinical Trials
Clinical Development
Business Analysis
Regulatory Affairs
Business Intelligence
FDA
Biotechnology
GMP
Change Management
Oncology
Change Control
Food & Drug Law
Drug Development
Patents
Trademarks
Regulatory Requirements
Pharmaceutics
Sop
GCP
IND
CTMS
Clinical Data Management
Drug Discovery
Analytical Chemistry
V&V
CAPA
GxP
GLP
Technology Transfer
Parenteral
Quality Assurance
Pharmacovigilance
Six Sigma
Regulatory Submissions
EDC
Chemistry
Medical Devices
Lifesciences
CRO
GAMP
Quality System
LIMS
Cross-functional Team Leadership
Cleaning Validation
Aseptic Processing
Quality Auditing
Food And Drug Law
Cross Functional Team Leadership
Management
Integration
Leadership
Public Speaking
Customer Service
Strategic Planning
David Paul Summary
David Paul, based in Indianapolis, IN, US, is currently a Senior Director, Regulatory Affairs CMC at Loxo@Lilly. David Paul brings experience from previous roles at Loxo at Lilly Oncology (Eli Lilly and Company). David Paul holds a 2006 - 2010 Juris Doctorate @ Indiana University School of Law—Indianapolis. With a robust skill set that includes Pharmaceutical Industry, Computer System Validation, Validation, 21 CFR Part 11, Clinical Trials and more. David Paul has 3 emails and 2 mobile phone numbers on RocketReach.
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