2014 -2015 Director Regulatory Solutions, Regulatory SME @ NextDocs
2001 -2014 Director, Regulatory Affairs @
Brooke C. Education
Northeastern University 2007-2008
Northeastern University
Graduate Certificate (International Regulatory Affairs)
2004-2006
Holy Family University
BA (Computer Management Information Systems)
1998-2000
Brooke C. Skills
Regulations
Clinical Trials
Public Speaking
Computer System Validation
GMP
eCTD
CTMS
Biotechnology
Regulatory Affairs
Change Control
Life Sciences
Validation
Medical Devices
Regulatory Requirements
Pharmacovigilance
Microsoft Office
Lifesciences
GCP
Cross Functional Team Leadership
Document Management
Clinical Development
U.S. Food And Drug Administration Fda
Regulatory Submissions
Documentum
Management
Electronic Common Technical Document Ectd
Project Management
Pharmaceutical Industry
FDA
Integration
Sop
21 CFR Part 11
IND
u.s. Food and Drug Administration
Electronic Common Technical Document
Good Clinical Practice
Standard Operating Procedure
Nonprofit Organizations
Business Process
Federal Regulations
Team Development
Brooke C. Summary
Brooke C., based in Golden, CO, US, is currently a Vice President, Advisory and Delivery at Epista Life Science. Brooke C. brings experience from previous roles at Accumulus Synergy, NNIT and Youth STEM Foundation - 501(c)(3) Non-Profit. Brooke C. holds a 2007 - 2008 Northeastern University. With a robust skill set that includes Regulations, Clinical Trials, Public Speaking, Computer System Validation, GMP and more. Brooke C. has 1 emails and 5 mobile phone numbers on RocketReach.
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