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Sean Spence Location
Indianapolis, IN, US
Sean Spence Work
Director - Regulatory | Drug Delivery and Digital Health @ Eli Lilly and Company (October 2023 - Present)
Sr. Research Scientist - Regulatory | Drug Delivery and Digital Health @ Eli Lilly and Company (January 2022 - October 2023)
Regulatory Affairs Manager @ (October 2014 - January 2022)
Regulatory Affairs Specialist and Team Lead @ (September 2011 - October 2014)
QAC Laboratory Analyst and Supervisor @ (September 2005 - September 2011)
Adv. Quality Control Chemist @ (January 2005 - July 2005)
Sean Spence Education
Purdue University
BS (Biology)
2000-2004
Sean Spence Skills
Regulatory Affairs
FDA
Medical Devices
ISO 13485
Regulatory Submissions
CAPA
Validation
GMP
Quality System
Design Control
Pharmaceutical Industry
V&V
Combination Products
Product Launch
Quality Control
Biotechnology
Regulatory Requirements
Product Development
Life Sciences
SOP
ISO 14971
Biomedical Engineering
Clinical Trials
Leadership
Business Analysis
Microsoft Word
Training
Customer Service
Microsoft Excel
Sean Spence Summary
Sean Spence, based in Indianapolis, IN, US, is currently a Director - Regulatory | Drug Delivery and Digital Health at Eli Lilly and Company. Sean Spence brings experience from previous roles at Eli Lilly and Company, NICO Corporation and Cook Medical. Sean Spence holds a 2000 - 2004 BS in Biology @ Purdue University. With a robust skill set that includes Regulatory Affairs, FDA, Medical Devices, ISO 13485, Regulatory Submissions and more. Sean Spence has 2 emails and 1 mobile phone numbers on RocketReach.
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