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Sean O'Bryan Location
Cambridge, MA, US
Sean O'Bryan Work
SVP, Head of Regulatory Affairs and Quality Assurance @ (August 2023 - Present)
Founder and Chief Consultant @ (January 2022 - Present)
SVP, Global Head of Regulatory Affairs @ (November 2020 - January 2022)
SVP, Regulatory Affairs and Quality Assurance @ (December 2018 - November 2020)
VP, Regulatory Affairs and Quality Assurance @ LYSOGENE (January 2016 - December 2018)
Sr. Director, Regulatory Affairs @ (August 2014 - October 2015)
Director, Regulatory Affairs @ (April 2006 - August 2014)
Sean O'Bryan Education
Boston U
Bachelor of Science (Environmental Science)
1989-1993
Sean O'Bryan Skills
Regulatory Strategy Development
Cross Functional Team Building
Quality Assurance
Regulatory CMC
U.S. Food and Drug Administration (FDA)
MHRA
Program Management
Biotechnology
Regulatory Affairs
BLA
FDA
21 CFR Part 11
EMA
ATMP
CTAs
MAA
IDE
IND
Paediatric Requirements
Lifesciences
Medical Device R&d
Continuous Improvement
Validation
Medical Devices
Sop
Process Improvement
Life Sciences
Panel Meetings
CAPA
Strategic Planning
Row
Leadership
GMP
GLP
Project Management
Technology Transfer
Pharmaceutical Industry
Combination Products
Change Control
Regulatory Submissions
Strategy
Medical Device Directive
Orphan Drugs
Sean O'Bryan Summary
Sean O'Bryan, based in Cambridge, MA, US, is currently a SVP, Head of Regulatory Affairs and Quality Assurance at Sonoma Biotherapeutics. Sean O'Bryan brings experience from previous roles at Accelerated Biologics Consulting, Freeline, AXOVANT SCIENCES, INC. and LYSOGENE. Sean O'Bryan holds a 1989 - 1993 Bachelor of Science in Environmental Science @ Boston U. With a robust skill set that includes Regulatory Strategy Development, Cross Functional Team Building, Quality Assurance, Regulatory CMC, U.S. Food and Drug Administration (FDA) and more. Sean O'Bryan has 3 emails and 2 mobile phone numbers on RocketReach.
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