2023 -2024 Vice President, Regulatory Affairs and Medical Writing @
2021 -2021 SVP, Regulatory Affairs @
2020 -2021 VP, Global Head of Regulatory and Quality @
2019 -2020 VP, Head of Regulatory Affairs @
2018 -2019 VP, Global Regulatory Affairs @
2015 -2018 Executive Director, Global Regulatory Affairs @
2013 -2015 Director, Global Regulatory Affairs @
2012 -2013 Principal Consultant @
2004 -2012 Interdisciplinary Supervisor @
2003 -2004 Consultant and Project Manager @ Salamandra, LLC
1999 -2003 Pharmacology Doctoral Program Graduate Student @
Molly Shea Education
Partnership for Public Service
(Excellence in Government- Leadership)
2010-2011
University of Minnesota Medical School
Ph.D. (Pharmacology)
1999-2003
University of Minnesota
B.S. (Biology)
1992-1997
University of Minnesota
B.A. (Anthropology)
1992-1997
Wayzata
Molly Shea Skills
Regulatory Affairs
FDA
Biotechnology
Lifesciences
Pharmacology
Pharmaceutical Industry
IND
Toxicology
Pharmacokinetics
Clinical Development
Sop
Tissue Culture
GLP
Regulatory Submissions
CRO
Drug Development
Drug Discovery
Molecular Biology
In Vitro
Biochemistry
Pharmaceutics
R&D
Oncology
Medical Devices
Assay Development
NDA
Protein Chemistry
Life Sciences
U.S. Food and Drug Administration (FDA)
Sales
Team Building
Business Development
GMP
Microsoft Office
Strategic Planning
Leadership
Marketing
Capital Markets
Risk Management
Financial Modeling
u.s. Food and Drug Administration Fda
u.s. Food and Drug Administration
Molly Shea Summary
Molly Shea, based in Boston, MA, US, is currently a Senior Vice President, Global Regulatory Affairs at BioCryst Pharmaceuticals, Inc.. Molly Shea brings experience from previous roles at Shea Regulatory Science Advisors, LLC, BlueRock Therapeutics, Atsena Therapeutics and Scholar Rock. Molly Shea holds a 2010 - 2011 Partnership for Public Service. With a robust skill set that includes Regulatory Affairs, FDA, Biotechnology, Lifesciences, Pharmacology and more. Molly Shea has 3 emails and 1 mobile phone numbers on RocketReach.
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