Top Director, Regulatory Affairs in Greater San Diego Area
Tom Gutierrez
Senior Director, Regulatory Affairs and Quality Assurance
Greater San Diego Area
Senior Director, Regulatory Affairs and Quality Assurance
Associate Director, Regulatory Affairs
Director, Regulatory Affairs
R&D Product Engineer
California State Polytechnic University-Pomona
Recommendations: 15
Medical Devices
ISO 14971
ISO 13485
FDA
Design Control
CAPA
People Skills
Regulatory Affairs
t****[email protected]
Alessandro Lobbia
Executive Director, Regulatory Affairs
Greater San Diego Area
Executive Director, Regulatory Affairs
Senior Director, Head of Regulatory Affairs and Quality Assurance
Senior Regulatory Affairs and Quality Consultant
Cadence Pharmaceuticals
Università degli Studi di Padova
Recommendations: 8
eCTD
European Union
Regulatory Submissions
FDA
Regulatory Affairs
Biotechnology
GMP
IND
s****[email protected]
Michelle Sands
Manager, Regulatory Affairs
Greater San Diego Area
Manager, Regulatory Affairs
Regulatory Affairs Associate
Associate Director, Regulatory Affairs
Senior Manager, Regulatory Affairs
Scientist
San Diego State University-California State University
University of Rhode Island
UC Irvine
Recommendations: 2
Drug Discovery
GLP
Oncology
IND
Pharmacokinetics
In Vitro
Regulatory Submissions
In Vivo
m****[email protected]
j****[email protected]
Alan Maderazo
Associate Director, Regulatory Affairs
Greater San Diego Area
Associate Director, Regulatory Affairs
Principal Regulatory Affairs Associate
Sr. Regulatory Affairs Specialist
Senior Manager, Regulatory Affairs
VP, Quality, Regulatory & Clinical Affairs
University of Massachusetts Medical School
University of Connecticut
Recommendations: 0
Sop
Quality Assurance
ISO 13485
FDA
Biotechnology
CAPA
Computer System...
Regulatory Affairs
a****[email protected]
Tiffany Baumann
Director, Clinical Operations
Greater San Diego Area
Director, Clinical Operations
Manager, Regulatory Affairs
Associate Director, Clinical Operations
Clinical Project Manager
Clinical Project Specialist
Clinical Operations Associate
Research Associate II, Dept. Neuroscience
Research Associate
Executive Director, Regulatory Affairs
Director, Regulatory Affairs
Associate Director, Regulatory Affairs
Assistant Director, Regulatory Affairs
University of California, Los Angeles
Recommendations: 0
Clinical Development
Clinical Research
Neuroscience
Clinical Trials
Drug Development
CTMS
CRO
EDC
t****[email protected]
Kathleen Gibbon
Sr. Director, Global Regulatory Affairs
Greater San Diego Area
Sr. Director, Global Regulatory Affairs
Sr. Director, Regulatory Affairs
Manager, Regulatory and Clinical Affairs
Manager, Regulatory Affairs
Sr. Specialist, Regulatory Affairs
University of California, Berkeley
Recommendations: 0
Drug Development
Pharmaceutics
Clinical Development
Regulatory Affairs
IND
Biotechnology
Regulatory Submissions
Oncology
k****[email protected]
Elizabeth Gordon
Microbiologist
Greater San Diego Area
Microbiologist
President
Senior Vice President, Regulatory Affairs
Vice President Regulatory Affairs
Sr. Director, Regulatory Affairs
Vice President Regulatory Affairs
Special Assistant to the Director, Acting Associate Director for Regulatory Policy, and Reviewer
Science, Engineering, and Diplomacy Fellow
Vice President Regulatory Affairs, Head of Regulatory Affairs
University of Maryland University College
Uniformed Services University of the Health Sciences
University of Rhode Island
Recommendations: 0
FDA
e****[email protected]
Ron Domingo
Senior Manager Regulatory Affairs
Greater San Diego Area
Senior Manager Regulatory Affairs
Regulatory Affairs Manager
Director of Regulatory Affairs
Associate Director, Regulatory Affairs
Worldwide Regulatory Strategy
San Diego State University-California State University
San Diego State University-California State University
Recommendations: 0
IND
Regulatory Submissions
Biotechnology
FDA
Regulatory Affairs
eCTD
GCP
ICH-GCP
r****[email protected]
r****[email protected]
Linda PhD
VP, Regulatory Affairs
Greater San Diego Area
VP, Regulatory Affairs
Board Of Trustees
VP, Regulatory Affairs and Quality Assurance
Director, Regulatory Affairs
Principal
R & D Advisory Board
Director, Regulatory Affairs
SVP, Regulatory Affairs and Quality Assurance
VP, Regulatory Affairs and Quality Assurance
Northwestern University
Lewis and Clark College
Roche Institute of Molecular Biology
Recommendations: 0
Drug Development
Biologics
Quality Assurance
Pharmaceutics
Strategy
FDA
Leadership
R&D
l****[email protected]
Sandra Matsumoto
Clinical Scientist
Greater San Diego Area
Clinical Scientist
Senior Scientist
Senior Manager, Regulatory Affairs
Director, Global Regulatory Affairs ► RAC-Certified Oversight+Compliance ★Medical Devices, Biologics
Genetic Project Manager
Senior Director, Global Regulatory Affairs ► Project Management & Oversight ★ Global Clinical Trials
Vice President, Global Regulatory Affairs ► FDA, Regulatory Compliance ★ Advancing Amphora for Women
Associate Director, Regulatory Affairs
Vice President, Regulatory Affairs ► FDA, Regulatory Strategy ★ Women’s Health
Genetic Services Manager
Manager, Regulatory Affairs
Vice President, Regulatory Affairs ► FDA, Regulatory Strategy ★ Innovative Product Development
University of Utah
California State University, Northridge
University of California, Los Angeles
Recommendations: 0
s****[email protected]
Amanda RAC
Senior Director, Regulatory Affairs
Greater San Diego Area
Senior Director, Regulatory Affairs
Senior Manager, Regulatory Affairs
Manager, Regulatory Affairs
Manager, Regulatory Affairs
Research Associate
University of California, Davis
San Diego State University
Recommendations: 0
Regulatory Affairs
Clinical Development
FDA
Regulatory Submissions
Biotechnology
Clinical Trials
Biopharmaceuticals
IND
a****[email protected]
Hutch Humphreys
student
Greater San Diego Area
student
Associate Product Line Manager
Director Regulatory Affairs
Associate Director, Regulatory Affairs
Senior Director Regulatory Affairs
Nuclear Submarine Officer
Regulatory Affairs Manager
Keck Graduate Institute - Claremont Colleges
The University of Kansas
University of North Carolina at Chapel Hill
Recommendations: 0
Regulatory Affairs Certified, US - 2004
Regulatory Affairs Certified, EU - 2010
h****[email protected]
Karin Hughes
Scientist, Applications Development
Greater San Diego Area
Scientist, Applications Development
Group Leader, Applications Development
Director Clinical and Regulatory Strategy
Worldwide Product Director Sepsis, Protein C & Stroke
Vice President R&D
Director Product Management
Director Applications Development & Director Manufacturing
Director, Regulatory Affairs
Vice President Clinical & Regulatory Strategy
Global Product Director - Ischemia
Senior Vice President Regulatory & Quality
University of Virginia
Hartwick College
Recommendations: 0
Medical Devices
Product Development
Quality Assurance
FDA
Strategic Planning
Clinical Research
Regulatory Affairs
Pharmaceutical Industry
k****[email protected]
k****[email protected]
Paul Mason
Sr Director, Regulatory Affairs
Greater San Diego Area
Sr Director, Regulatory Affairs
VP, Regulatory Affairs
Sr Reg Analyst/Biostatistican/CRA
Manager, Regulatory Submissions
Director, Regulatory Submissions
VP, Regulatory Affairs/Quality Assurance
VP, RA/CA/QA
Class III Medical Device Regulatory/Clinical/Quality Professional
Class III Medical Device Regulatory/Clinical/Quality Professional
Duke University
The University of Texas at Austin
Recommendations: 0
Regulatory Affairs
Design Control
ISO 13485
Medical Devices
FDA
PMA
Regulatory Submissions
ISO 14971
p****[email protected]
Mary Wilhelm
Senior Director, Regulatory Affairs
Greater San Diego Area
Senior Director, Regulatory Affairs
Adjunct Faculty
Director, Regulatory Affairs
Associate Director, Regulatory Affairs & Quality Assurance
Senior Manager, Regulatory Affairs & Quality Assurance
Regulatory Affairs Manager
Quality Assurance Specialist
San Diego State University-California State University
Purdue University
Purdue University
Purdue University
Recommendations: 0
IND
Biotechnology
FDA
Regulatory Affairs
Pharmaceutical Industry
GMP
Drug Development
Regulatory Submissions
m****[email protected]
s****[email protected]
John F. Wood
Vice President, Regulatory Affairs
Greater San Diego Area
Vice President, Regulatory Affairs
Volunteer; BOD member
Volunteer; BOD member
Vice President, Regulatory Affairs and Quality
Executive Director, Exenatide Alliance Leader
Executive Director, Regulatory Affairs
Associate Director, Regulatory Affairs
Manager Regulatory Affairs
Sr. Regulatory Associate & Lab Tech
Lab Tech/REU Fellow
University of Phoenix
University of California, San Diego
Recommendations: 0
j****[email protected]
j*****@lithera.com
Rachael Williamson
Senior Regulatory Affairs Manager
Greater San Diego Area
Senior Regulatory Affairs Manager
Regulatory Consultant
Associate Director, Regulatory Affairs
Research Asoociate
Regulatory Affairs Specialist
Clinical Research Associate
Senior Regulatory Affairs Manager
San Diego State University-California State University
UC San Diego
Recommendations: 0
Design Control
ISO 13485
Regulatory Affairs
Medical Devices
Biotechnology
Sop
GMP
IVD
w****[email protected]
r****[email protected]
Tracy Parrott
Chief Development Officer
Greater San Diego Area
Chief Development Officer
Exec Dir, Project Management
Director, Project Leader
Assoc Director, Regulatory Affairs
Manager, Regulatory Affairs
Sr. Scientist
Indiana University Robert H. McKinney School of Law
Indiana University Bloomington
Recommendations: 0
Pharmaceutical Industry
Clinical Development
Regulatory Affairs
Entrepreneurship
Oncology
Team Leadership
CMC
Clinical Operations
t****[email protected]
Glenn Sherman
Consultant
Greater San Diego Area
Consultant
Director, Regulatory Affairs
Associate Director, Regulatory Affairs
Associate Director, Regulatory Affairs
Senior Manager, Regulatory Affairs
Microbiologist
Senior Staff Fellow, NIAID
Rutgers University-New Brunswick
University of North Carolina at Chapel Hill
Recommendations: 0
s****[email protected]
Elisabeth Kirkbright
Associate Director, CMC Regulatory Affairs
Greater San Diego Area
Associate Director, CMC Regulatory Affairs
Associate Director, Regulatory Affairs
Associate Director, CMC Regulatory
Associate Director CMC Regulatory Affairs
Associate Director, CMC Regulatory Affairs
Rutgers University
Recommendations: 0
CMC Regulatory Affairs
e****[email protected]
Jodi Parsons
Director of Regulatory Affairs
Greater San Diego Area
Director of Regulatory Affairs
Senior Director of Regulatory Affairs
Senior Director Regulatory Affairs
Assistant Director, Regulatory Affairs
Regulatory Affairs Consultant
Senior Director/Consultant, Regulatory Affairs
Associate Director, Regulatory Affairs
Assistant Director, Development Chemistry
Emory University
University of Miami
Recommendations: 0
Regulatory Affairs
Regulatory Submissions
IND
Drug Development
j*****@sbcglobal.net
Leanne Kiviharju
VP, Regulatory Affairs
Greater San Diego Area
VP, Regulatory Affairs
VP, Regulatory Affairs, North America
Senior Director, Regulatory Affairs
Regulatory and Quality consultant
VP, Clinical, Regulatory Affairs &Quality Assurance
Senior Director, Regulatory Affairs
University of Regina
Recommendations: 0
l****[email protected]
Reuben Lawson
Clinical Research Manager
Greater San Diego Area
Clinical Research Manager
Associate Director, Regulatory Affairs
Senior Director, Regulatory Affairs / Clinical
Senior Regulatory Affairs Manager
Regulatory Affairs Manager
Compliance Manager
The University of Waikato
The University of Waikato
The University of Waikato
Recommendations: 0
Medical Devices
FDA GMP
Product Development
Regulatory Affairs
FDA
Change Management
ISO 13485
Clinical Research
r****[email protected]
paula morgan
Senior Director, Regulatory Affairs
Greater San Diego Area
Senior Director, Regulatory Affairs
Company Name
Zimmer Dental (formerly Sulzer Dental)
research associate
R&D
University of New Hampshire
Recommendations: 0
s****[email protected]
Bruce Lu
Senior Director, Regulatory Affairs
Greater San Diego Area
Senior Director, Regulatory Affairs
Director, Regulatory Affairs
Senior Manager, Regulatory Affairs
Director, Regulatory Affairs
Director, Regulatory Affairs
Manager, Regulatory Affairs
Director, Regulatory Affairs
Director, Regulatory Affairs and Quality Assurance
University of Arizona
China Medical University (TW)
Recommendations: 0
IND
Regulations
Regulatory Submissions
NDA
Quality Assurance
Management
Regulatory Affairs
GMP
b****[email protected]
Christine Schulteis
Senior Director, Regulatory Affairs
Greater San Diego Area
Senior Director, Regulatory Affairs
Senior Director, Global Regulatory Affairs
Senior Director, Regulatory and Medical Communications
Director, Medical Writing
Associate Director, Medical Disclosures
Group Leader, Opthalmology
University of California, Los Angeles
University of California, Los Angeles
Recommendations: 0
Clinical Trials
Diabetes
Medical Writing
Clinical Development
Drug Development
Endocrinology
Biotechnology
Pharmaceutical Industry
c****[email protected]
Min RAC
Director, Regulatory Affairs
Greater San Diego Area
Director, Regulatory Affairs
Global Regulatory Lead, Global Regulatory Affairs
Regulatory Lead, Regulatory Affairs
Global Regulatory Lead, Regulatory Strategy and Liaison, Global Regulatory Affairs, Shire HGT
University of Southern California
Rutgers/UMDNJ
High School affiliated with Nanjing Normal University
Recommendations: 0
Vernon Trimble
Manager, Regulatory Affairs/Quality Assurance
Greater San Diego Area
Manager, Regulatory Affairs/Quality Assurance
Director, Regulatory Affairs/Quality Assurance
Vice President, Regulatory Affairs/Quality Assurance
Vice President, Regulatory, Quality & Clinical Affairs
Vice President Regulatory Affairs Quality Assurance
Vice President, Regulatory Affairs/Quality Assurance
San Diego State University-California State University
Maryville University of Saint Louis
Maryville University of Saint Louis
Recommendations: 0
• Over 20 years experience in resolving regulatory issues with the FDA
• Submission and approval of 510(k)s
• Company Leader and Spokesperson for FDA Audits/Inspections
ISO 13485
Medical Devices
CAPA
V&V
FDA
Jennifer RAC
Director, Regulatory Affairs
Greater San Diego Area
Director, Regulatory Affairs
Regulatory Review Scientist
IOTF Fellow
Postdoctoral Fellow
Postdoctoral Fellow
University of California San Diego
University of California, San Francisco
Recommendations: 0
