Jamie L Austin
President, Biotechnology Business Development and Global Lead For Regulatory and Quality Practice
Jamie L Austin is a eficient expert, who works in Jet Strategy Partners on the position of President, Biotechnology Business Development and Global Lead For Regulatory and Quality Practice since 2019. This expert gained professional experience in more than ten positions at different companies. Jamie L Austin went to the University of Michigan and got education from 2010 to 2015. Jamie L Austin has professional qualifications: Regulatory Affairs Certified (Canada), Regulatory Affairs Certified (Us), and Regulatory Affairs Professional Society. Rockville, Maryland is the area, where this expert was known to be situated. The professional's e-mail and phone can be easily accessed through Connexy on demand.
Name variants:
James Austin,
Jameson Austin,
Jamesina Austin
Contact Information
Last Update
Jun 28, 2022
Email
au**@aol.com
Location
Rockville, MD
Company
Jet Strategy Partners
Workplace
President, Biotechnology Business Development and Global Lead For Regulatory and Quality Practice
Work History
President, Biotechnology Business Development and Global Lead For Regulatory and Quality Practice
from 2019
Regulatory Affairs , Director
Developed, led, and implemented US and global regulatory strategy to facilitate the development of various late-stage/marketed oncology assets. Activities included: Facilitating Health Autho...
May 2016 — Dec 2017
Program Coordinator and Lecturer - Biotechnology
3400 north Charles Street Ave, Baltimore, MD 21204
Teach courses, advise students, and coordinate the Regenerative and Stem Cell Technology program within Center for Biotechnology Education. Duties include: Academic advising, coordination of...
from Dec 2017
Regulatory Strategy Consultant
Contractual regulatory consulting services specializing in developing and directing regulatory strategy (early-and late-stage clinical; pre-IND through marketing applications) for biologics,...
from 2017
Regulatory Affairs, Global Strategy, Associate Director
60 Binney St, Cambridge, MA 02142
Developed, led, and executed global regulatory strategy to facilitate the development of novel biologic (gene and cell therapy) products in US, EU, and ROW. Activities included: Facilitating...
Aug 2015 — Apr 2016
Regulatory Affairs , Area Lead [Manager Through Associate Director
1 Waukegan Rd, North Chicago, IL 60064
Executed and managed regulatory activities to support the development, approval, and life cycle of products (NMEs and established compounds) in the US and Canada. Activities included: Manage...
Dec 2013 — Aug 2015
Regulatory Science Program Coordinator and Lecturer
3400 north Charles Street Ave, Baltimore, MD 21204
Taught courses, Advised students, and coordinated Regulatory Science program within Center for Biotechnology Education. Duties included: Academic advising, coordination of recruitment events...
Mar 2011 — Jun 2014
Managing Member and Principal Regulatory Consultant
Established and led strategic plan for consulting practice (Managing Member). Directed regulatory activities for global product commercialization and life cycle management (Principal Regulat...
Mar 2010 — Mar 2014
Regulatory Consultant
9001 Wesleyan Rd SUITE 200, Indianapolis, IN 46268
Led regulatory activities to support commercialization, life cycle management, and compliance for assigned projects. Regulatory consulting services included: Support and advice for agency in...
Apr 2008 — Mar 2010
Consultant
Interpreted federal and local regulations to ensure compliance. Duties included: Translation of regulations into electronic management systems for global compliance assurance projects
Sep 2007 — Apr 2008
Education
2010 — 2015
2006 — 2008
2005 — 2006
2000 — 2004
Occupations
Executive
Chairperson
Scientist
Biotechnology Professional
Director
Doctor
Oncologist
Chief Executive
Biologist
Biological Scientist
Operations Manager
Medical Practice Professional
Medical Practitioner
Skills
Regulatory Affairs
Fda
Biotechnology
Pharmaceutical Industry
Medical Devices
Clinical Trials
Regulatory Submissions
Infectious Diseases
Drug Delivery
Life Sciences
Lifesciences
Technology Transfer
Gmp
Immunology
Glp
Molecular Biology
Biochemistry
Cell Biology
U.s. Food and Drug Administration
Regulatory Strategy Development
Cell Culture
Pcr
Regulatory Requirements
Ind
Virology
Combination Products
Fluorescence Microscopy
Strategy
Oncology
Clinical Development
Drug Development
Biopharmaceuticals
Management
Biosimilars