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Kristen Manion Location
Wayne, PA, US
Kristen Manion Work
Vice President Regulatory Affairs Quality and Manufacturing @ (January 2023 - Present)
Vice President of Regulatory Affairs and Quality @ (July 2021 - January 2023)
Executive Director Regulatory and Quality @ (July 2019 - July 2021)
Senior Director Regulatory Affairs (CMC) and Quality Assurance @ (January 2017 - July 2019)
Director Regulatory Affairs (CMC) and Quality Assurance @ (January 2016 - January 2017)
Director Global Regulatory Strategy - CMC (US) @ (July 2009 - December 2015)
Regulatory Scientist @ Merck and Company, Incorporated (January 1999 - January 2009)
Kristen Manion Skills
Pharmaceutical Industry
Regulatory Submissions
Regulatory Affairs
GMP
FDA
Sop
Clinical Development
Validation
Quality Assurance
CAPA
Regulatory Requirements
Cross-functional Team Leadership
IND
Technology Transfer
Change Control
Drug Development
Pharmaceutics
Clinical Trials
GxP
CMC
Biopharmaceuticals
Pharmacovigilance
u.s. Food and Drug Administration Fda
Microsoft Excel
Cross Functional Team
Standard Operating Procedure Sop
Strategy
Cross Functional Team Leadership
Chemistry
Project Management
u.s. Food and Drug Administration
Standard Operating Procedure
Kristen Manion Summary
Kristen Manion, based in Wayne, PA, US, is currently a Vice President Regulatory Affairs Quality and Manufacturing at Paratek Pharmaceuticals. Kristen Manion brings experience from previous roles at Paratek Pharmaceuticals. With a robust skill set that includes Pharmaceutical Industry, Regulatory Submissions, Regulatory Affairs, GMP, FDA and more. Kristen Manion has 2 emails and 3 mobile phone numbers on RocketReach.
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