Top Director, Regulatory Affairs in Greater Boston Area
Alu Chatterjee
Senior Director, Regulatory Affairs
Greater Boston Area
Senior Director, Regulatory Affairs
Intarcia Therapeutics, Inc.
Consultant, Project Management
Pfizer
Baylor College of Medicine
University of Windsor
University of Rhode Island - College of Business Administration
Recommendations: 5
Translational Medicine
Personalized Medicine
Research Project...
Biomarkers
Drug Discovery
Clinical Development
In Vitro
Genomics
a****[email protected]
a****[email protected]
Ari Sobel
Manager, Regulatory Affairs - Medical Devices
Greater Boston Area
Manager, Regulatory Affairs - Medical Devices
Quality Assurance Associate
Regulatory Affairs Consultant
Director, Regulatory Affairs
Director, Quality and Regulatory Affairs
Manager, Quality and Regulatory Affairs
Manager, Regulatory Affairs & Process Excellence
Quality Engineer
Technion - Israel Institute of Technology
Technion - Israel Institute of Technology
Tel Aviv University
Recommendations: 4
Regulatory Affairs
Medical Devices
FDA
ISO
Quality Assurance
Quality Systems
ISO 13485
510 K
a****[email protected]
Joseph RAC
Sr. Manager, Regulatory Affairs
Greater Boston Area
Sr. Manager, Regulatory Affairs
Associate Director, Regulatory Affairs
Associate Director, Global Regulatory Affairs
Regulatory Consultant for Global Submissions
Associate Director, Regulatory Affairs
International Regulatory Affairs Manager
Global Regulatory Affairs Transversal Therapeutic Area Lead
Regulatory Affairs Manager
Manager, Regulatory Affairs
Northeastern University
Recommendations: 4
510 K
Medical Devices
Life Sciences
PMA
EU
CE marking
FDA
GMP
j****[email protected]
Lynn Bayless
Head, Regulatory Affairs Mustang Bio.
Greater Boston Area
Head, Regulatory Affairs Mustang Bio.
Director Regulatory Affairs
Pharmacologist
Senior Director Regulatory Affairs
Associate Director, Regulatory Affairs
Sr. Research Scientist
Senior Regulatory Affairs Associate
Massachusetts College of Pharmacy and Health Sciences
Quinnipiac University
Recommendations: 2
Regulatory Submissions
Clinical Development
Regulatory Affairs
eCTD
IND
Clinical Trials
Strategy
Regulatory Requirements
l****[email protected]
Mark De Rosch
Vice President, Regulatory Affairs
Greater Boston Area
Vice President, Regulatory Affairs
Vice President, Regulatory Drugs/Biologics & Head, US Operations
Regulatory Consultant
Vice President, Head of Global Regulatory Affairs
Senior Director, Global Clinical Regulatory Strategy
Director, Regulatory Affairs
Associate Director, Regulatory Affairs
Associate Director, Product Development
Research Chemist
Post-doctoral Fellow
University of California, San Diego
University of Wisconsin-Parkside
Recommendations: 2
Clinical Development
Drug Development
Regulatory Affairs
Regulatory Submissions
Pharmaceutical Industry
IND
Biotechnology
Clinical Trials
m****[email protected]
Cynthia Courtney
Director, Promotional Regulatory Affairs
Greater Boston Area
Director, Promotional Regulatory Affairs
Sr Business Information Specialist
Librarian
Sr Director, Regulatory Affairs, Advertising, Promotion and Labeling
Director, Promotion Integrity (Regulatory Affairs)
Sr Manager, Regulatory Intelligence
Senior Manager, Information Resources
Director, Regulatory Affairs (Advertising and Promotion)
Associate Director, Regulatory Affairs (Advertising and Promotion)
Budget Analyst, Program Manager
Sr Manager, Information Resources
Harvard University Kennedy School of Government
Cornell University
Houghton High School
Recommendations: 2
Regulatory Affairs
Advertising and...
Scientific...
Compliance
Informed Consent and...
Group Presentations
Training and Development
Writing
c****[email protected]
John DeLucia
Director, Regulatory Affairs
Greater Boston Area
Director, Regulatory Affairs
VP, Regulatory Affairs and Quality Assurance
VP, Regulatory, Quality, and Clinicals
Regulatory/Quality/Clinical Consultant
Mgr, QA; Director RA/QA; VP, RA/QA
VP, Regulatory Affairs, Clinical Affairs and Quality Assurance
VP, Regulatory and Clinical Affairs and Quality Assurance
VP, RA/QA
Fairfield University
Quinnipiac University
SUNY
Recommendations: 2
Medical Devices
Clinical Trials
Biomedical Engineering
Hospitals
ISO 13485
FDA
Design Control
CAPA
j****[email protected]
Jody Schiloski
Associate Director Regulatory Affairs
Greater Boston Area
Associate Director Regulatory Affairs
Sr. Regulatory Affairs Associate III-IV
Associate Director, Regulatory Operations
Regulatory Affairs Associate III
Sr. Regulatory Affairs Associate
Director, Regulatory Affairs
Sr. Regulatory Affairs Associate
Director of Regulatory Affairs
Recommendations: 2
Regulatory Affairs
FDA
Regulatory Submissions
Regulations
Pharmaceutical Industry
Biotechnology
Clinical Development
Drug Development
j****[email protected]
Wing Ng
Director, Regulatory Affairs
Greater Boston Area
Director, Regulatory Affairs
Assoc. Director, Regulatory Affairs
Manager, Regulatory Affairs
Sr. Regulatory Specialist
Regulatory Specialist I/II
Framingham State University
Framingham State University
Recommendations: 2
Medical Devices
FDA
ISO 13485
Design Control
CAPA
Quality System
21 CFR Part 11
Change Control
w****[email protected]
Darlene Noci
Global Regulatory Strategy Lead, Oncology
Greater Boston Area
Global Regulatory Strategy Lead, Oncology
Director, Regulatory Affairs
Global Regulatory Lead, Oncology
Associate Director - Director, Regulatory Affairs
Sr. Associate - Manager
Regulatory Operations/Information Coordinator
Harvard University
Adelphi University
Recommendations: 1
Regulatory Submissions
Pharmaceutical Industry
Regulatory Affairs
Biotechnology
Oncology
FDA
Lifesciences
GCP
d****[email protected]
Holly Maier
Associate Director, Regulatory Affairs
Greater Boston Area
Associate Director, Regulatory Affairs
Associate Director, Medical Publications
Senior Manager, Medical Communications
Manager, Medical Communications
Manager of Scientific Communications
Senior Medical Writer
Medical Affairs Scientist II
Postdoctoral fellow
Graduate student
University of Colorado Anschutz Medical Campus
Washington State University
Recommendations: 1
Immunology
Diabetes
Central Nervous System
Wound Care
Clinical Development
Clinical Research
Medical Writing
Medical Affairs
h****[email protected]
Bao Le
Associate Director, Regulatory Affairs
Greater Boston Area
Associate Director, Regulatory Affairs
Senior Manager, Regulatory Affairs
Manager, Regulatory Affairs
Regulatory Affairs
Scientist / Quality Control Stability Specialist
Analyst
Regis College
Recommendations: 1
Regulatory Affairs
Clinical Trials
Biotechnology
FDA
Pharmaceutical Industry
Clinical Development
IND
b*****@hotmail.com
Christine Guertin
Director, Regultory Affairs
Greater Boston Area
Director, Regultory Affairs
Vice President of Regulatory Affairs and Quality Assurance
Regulatory Affairs Information Coordinator II
Regulatory Affairs Associate II
Associate Director, Regulatory Affairs
Head of Regulatory Affairs
Regis College
Saint Joseph's College
Wakefield High School
Recommendations: 1
Pharmaceutical Industry
Regulatory Affairs
Regulatory Submissions
Clinical Development
FDA
GCP
21 CFR Part 11
Biopharmaceuticals
r****[email protected]
Catherine Foulon
President and Lead Consultant
Greater Boston Area
President and Lead Consultant
Consultant, Regulatory CMC
Consultant, Regulatory Submission
Consultant, Regulatory CMC
Consultant, Global Regulatory CMC
Consultant, Global Regulatory CMC
Consultant, Regulatory CMC
Project Manager, Global Regulatory CMC
Director, Regulatory Affairs
Director, Radiopharmaceutical Development
Lead, Timeline and Resource Management
Project Manager
University of Tours, France
Recommendations: 1
Regulatory Affairs
Pharmaceutical Industry
FDA
GMP
Biotechnology
Validation
IND
Regulatory Submissions
c****[email protected]
Seth Shapiro
Director, Chemistry Manufactuing and Controls
Greater Boston Area
Director, Chemistry Manufactuing and Controls
Senior Director, Regulatory Affairs
Director, Global Regualtory Affairs. (Chemistry, Manufacturing and Controls) U.S. Strategy Lead
Director, CMC (Chemistry Manufacturing and Controls) Regulatory Affairs
Sr. Chemistry, Manufacturing and Controls Associate
Massachusetts College of Pharmacy and Health Sciences
Westfield State University
Recommendations: 1
cGMP
Regulatory Affairs
Compliance
Biotechnology
IND
Pharmaceuticals
Infectious Diseases
Manufacturing
s****[email protected]
Robert Michalik, J.D., RAC
Principal Consultant
Greater Boston Area
Principal Consultant
Adjunct Faculty / M.S. Regulatory Affairs program
Director, Regulatory Affairs, Quality & Safety (Contractor)
Program Committee member
Founding member
Principal Regulatory Affairs Specialist
Regulatory Affairs Senior Specialist
Principal Consultant
R&D Scientist; Manager - Biopharma Manufacturing
Research Associate - Protein Chemist
Research Associate
Northeastern University
Suffolk University Law School
University of Massachusetts, Amherst
Recommendations: 1
FDA
510 K
IND
Regulatory Filings
Biopharmaceuticals
Medical Devices
Pharmaceutical Industry
Regulatory Affairs
r****[email protected]
Shreya M.
Regulatory Labeling and Promotion Intern
Greater Boston Area
Regulatory Labeling and Promotion Intern
Intern
Research Assistant
Global Regulatory Affairs Labeling
Manager, Regulatory Affairs
Regulatory Affairs
Associate Director, Regulatory Affairs
Senior Manager, Regulatory Affairs
Northeastern University
State University of New York at Buffalo - School of Medicine & Biomedical Sciences
Recommendations: 0
Regulatory Affairs
Labeling
IND
Regulatory Submissions
GLP
Oncology
Clinical Research
Pharmaceutical Industry
s****[email protected]
s****[email protected]
Elizabeth Mellen
Senior Director, Oncology Therapeutics
Greater Boston Area
Senior Director, Oncology Therapeutics
Director, Regulatory Affairs; Head of North America Regulatory Affairs
Associate Director, Head of North American Regulatory Affairs
Consultant, Regulatory Therapeutics
Associate Director, Regulatory
Senior Manger, Regulatory Affairs
Regulatory Project Manager
Regulatory Affairs Associate
Simmons College - Simmons School of Management
Massachusetts College of Pharmacy and Health Sciences
University of Massachusetts, Amherst
Recommendations: 0
Biotechnology
Regulatory Affairs
Pharmaceutical Industry
Oncology
Clinical Trials
Companion Diagnostics
Biologics
Diagnose
b****[email protected]
Margaret Vargo (Taleff)
Sr. Regulatory Coordinator
Greater Boston Area
Sr. Regulatory Coordinator
Director, Worldwide Regulatory Affairs
Senior Director, Regulatory Affairs
Vice President, Regulatory Affairs
Senior Regulatory Associate
Vice President, Regulatory Affairs
Vice President, Global Regulatory Affairs
University of Pennsylvania
University of Pittsburgh
Recommendations: 0
m****[email protected]
Chuck Monahan
Associate Director Regulatory Affairs
Greater Boston Area
Associate Director Regulatory Affairs
Sr. Technical Associate
Sr. Manager Regulatory Affairs
Associate Director, Regulatory Affairs
Director Regulatory Affairs
Manager Regulatory Affairs
Head of Regualtory Affairs
Associate Director Regulatory Affairs
Massachusetts College of Pharmacy and Health Sciences
University of Rhode Island College of Pharmacy
St. John's High
Recommendations: 0
GCP
Biotechnology
Oncology
Regulatory Affairs
Drug Development
Regulatory Strategy Development
Clinical Development
Regulatory Submissions
c*****@charter.net
Alissa Minkoff
Senior Manager, Regulatory Affairs
Greater Boston Area
Senior Manager, Regulatory Affairs
Manager, Regulatory Affairs
Clinical Operations Internship
Senior Manager, Regulatory Affairs
Senior Regulatory Affairs Associate
Regulatory Operations Associate II
Sr. Regulatory Affairs Associate
Regulatory Affairs Associate II
Associate Director, Regulatory Affairs
Northeastern University
Boston University
Recommendations: 0
Regulatory Affairs
IND
eCTD
FDA
Regulatory Submissions
Clinical Development
CTAs
NDA
a****[email protected]
Carole Ann Cartier
Director, Regulatory Affairs
Greater Boston Area
Director, Regulatory Affairs
Associate Director, Regulatory Affairs
Director, Regulatory Affairs
Director, Regulatory Affairs
Director, Regulatory Affairs
Scientific & Competitive Intelligence / Regulatory Affairs - Regulatory Strategy & Intelligence
Associate Director, Regulatory Affairs
Regulatory Operations / Regulatory Policy & Intelligence
Manager, Regulatory Affairs
Manager, Regulatory Affairs
Regulatory Affairs / Quality Assurance
Fairleigh Dickinson University
Northeastern University
College of Saint Elizabeth
Recommendations: 0
c****[email protected]
Drew MPH
Director, Regulatory Affairs-CMC
Greater Boston Area
Director, Regulatory Affairs-CMC
Director of Regulatory Affairs
Health Services Officer
University of North Carolina at Greensboro
Mount St. Mary's University
Recommendations: 0
d****[email protected]
Karen Mahoney
Worldwide Senior Director, Regulatory Affairs
Greater Boston Area
Worldwide Senior Director, Regulatory Affairs
Senior Associate, Regulatory Affairs
Worldwide Senior Director, Regulatory Affairs Strategic Innovation and Spine
Corporate Regulatory Affairs Associate
WW Director, Regulatory Affairs, Codman
WW Director, Quality Engineering, DePuy Mitek
Roger Williams University School of Law
Fairfield University
East Catholic High School
Recommendations: 0
Medical Devices
Regulatory Affairs
FDA
Design Control
Spine
Pharmaceutical Industry
Clinical Trials
Validation
k****[email protected]
Mark Swarz
Associate Director, Regulatory Affairs
Greater Boston Area
Associate Director, Regulatory Affairs
Associate Director, Regulatory Affairs
Associate Director, Regulatory Affairs
Sr. Associate, Regulatory Affairs
Project Coordinator, Project Management
University of Michigan
Recommendations: 0
m****[email protected]
Daniel Phelan
Director of Regulatory Affairs
Greater Boston Area
Director of Regulatory Affairs
Director, Regulatory Affairs
Principal, Global Regulatory Affairs
Sr. Regulatory Affairs Specialist
Regulatory Affairs Manager
Quality Assurance Manager
Purdue University
Saint Anselm College
Recommendations: 0
Regulatory Requirements
FDA
Medical Devices
Quality System
Clinical Research
Validation
Design Control
Regulatory Affairs
w****[email protected]
Jennie Allewell
Director II, Worldwide Regulatory Affairs
Greater Boston Area
Director II, Worldwide Regulatory Affairs
Director II, Global Regulatory Affairs
Director, Regulatory Affairs
Recommendations: 0
j****[email protected]
Chuck Miller
Senior Vice President, Regulatory Affairs
Greater Boston Area
Senior Vice President, Regulatory Affairs
Director, Regulatory Affairs
Vice President Regulatory Affairs
Manager, Regulatory Affairs
Vice President Regulatory Affairs
Vaccine Research, Development, and Regulatory Affairs
Executive Director, Regulatory Affairs
Senior Regulatory Advisor
Senior Director, Regulatory Affairs (Executive Director - Merck)
Boston University
Recommendations: 0
Regulatory Affairs
Vaccines
R&D
Clinical Development
FDA
Clinical Research
Life Sciences
Commercialization
z****[email protected]
Stephanie Krogmeier
Senior Director, Regulatory Affairs CMC
Greater Boston Area
Senior Director, Regulatory Affairs CMC
Director, Regulatory Affairs CMC
Associate Director, Regulatory Affairs CMC
Sr.Manager Regulatory Affairs CMC
Manager, Regulatory Affairs CMC
Scientist II, Formulation Development
Scientist I, Formulation Development
The University of Kansas
Drake University
Recommendations: 0
Drug Discovery
Drug Development
IND
Clinical Trials
Formulation
Pharmaceutics
FDA
GCP
s****[email protected]
Sara Saltzman
Director, Regulatory Affairs
Greater Boston Area
Director, Regulatory Affairs
Senior Director, Regulatory Affairs
Associate Director, Regulatory Affairs
Vice President, Regulatory Affairs
Regulatory Affairs Consultant
Associate Director, Global Regulatory Strategy
Senior Director, Regulatory Affairs
Associate - Manager, Regulatory Affairs
Colby College
Recommendations: 0
IND
Global Drug Development
Regulatory Affairs
Oncology
Regulatory Submissions
Clinical Development
Clinical Trials
Lifesciences
s****[email protected]
Jennifer Dittman
Director Regulatory Affairs
Greater Boston Area
Director Regulatory Affairs
Director Regulatory Affairs
Associate Director, Regulatory Affairs
Adjunct Faculty
Quality Assurance Specialist
Project Manager
Northeastern University
University of Rhode Island
Recommendations: 0
Validation
GLP
FDA
GMP
eCTD
NDA
IND
Regulations
j****[email protected]
Catherine Hay
Sr. Director, Regulatory Affairs
Greater Boston Area
Sr. Director, Regulatory Affairs
Post-doctoral Research Fellow
Consultant, Regulatory Affairs
Consultant
Assoc. Deputy Director, Regulatory Affairs and Clinical Operations
Vice President, Regulatory Affairs
Director, Regulatory Affairs
Manager, Regulatory Affairs
Director, Regulatory Affairs
Senior Director, Regulatory Affairs
Natural Products Chemist
Senior Technical Associate, Worldwide Regulatory Affairs
Vice President, Regulatory Affairs
School of Pharmacy, U. of London
Recommendations: 0
Biotechnology
Regulatory Affairs
Pharmacology
Technology Transfer
GMP
CAPA
Biopharmaceuticals
FDA
c****[email protected]
c*****@visterrainc.com
Kerry Wentworth
Vice President, Clinical, Regulatory & Quality
Greater Boston Area
Vice President, Clinical, Regulatory & Quality
Manager, Regulatory Affairs
Chief Regulatory Officer
Senior Director, Regulatory Affairs
University of New Hampshire
Recommendations: 0
Clinical Development
Clinical Research
Regulatory Affairs
Biotechnology
Clinical Trials
Strategy
Drug Development
Change Control
k****[email protected]
Gail Shamsi
Associate Director, Regulatory Affairs
Greater Boston Area
Associate Director, Regulatory Affairs
Associate Director, Regulatory Affairs
Director, Regulatory Affairs
Principal Associate, Regulatory Compliance
Senior Investigator
Regulatory Lead
Associate Director, Regulatory Affairs
Boston University Questrom School of Business
University of New Hampshire
Recommendations: 0
Regulatory Affairs
Regulatory Submissions
FDA
GMP
Biotechnology
Global regulatory affairs
Regulatory CMC
Regulations
g****[email protected]
Michael Fuller
Director, Regulatory Affairs / Quality Assurance
Greater Boston Area
Director, Regulatory Affairs / Quality Assurance
RA / QA Manager
Regulatory Affairs Specialist
Quality Assurance Manager
Network Administrator
Operations Supervisor
Instrumentation Manager
Franklin Pierce University
Recommendations: 0
Operating Systems
Quality Assurance
Manufacturing
Procurement
XP
m****[email protected]
Heather Faulds
Vice President, Regulatory Affairs
Greater Boston Area
Vice President, Regulatory Affairs
Sr. Manager, Regulatory Affairs
Director, Regulatory Affairs
Sr. Director, Head - Global Regulatory Strategy
Associate Director, Regulatory Affairs
SVP, Regulatory Affairs
Sr. Director, Regulatory Affairs
SVP, Regulatory Sciences and Quality
Massachusetts College of Pharmacy and Health Sciences
University at Albany, SUNY
Recommendations: 0
IND
CMC
Biopharmaceuticals
Regulatory Submissions
Biotechnology
Drug Development
Clinical Development
Regulatory Affairs
h****[email protected]
Jim McMahon
Senior Director, Regulatory Affairs
Greater Boston Area
Senior Director, Regulatory Affairs
Manager, Regulatory Affairs
Associate Director Regulatory Affairs
Specialist I to Manager, Regulatory Affairs
Senior Director, Regulatory Affairs
Senior Director, Regulatory Affairs
Senior Director, Regulatory Affairs
Senior Manager, Regulatory Affairs
Director, Regulatory Affairs
Excelsior College
New England Institute of Technology
Recommendations: 0
FDA
ISO 13485
Medical Devices
Design Control
Regulatory Affairs
ISO 14971
CAPA
V&V
j****[email protected]
Joy RAC
Director, Regulatory Affairs, Global Regulatory Lead
Greater Boston Area
Director, Regulatory Affairs, Global Regulatory Lead
Regulatory Affairs
Postdoctoral research fellow
Recommendations: 0
Regulatory Affairs
Drug Development
Clinical Trials
Regulatory Submissions
Clinical Development
Medical Devices
Pharmaceutical Industry
NDA IND CMC Labeling
j****[email protected]
Shelley Mendenhall
Director of Regulatory CMC
Greater Boston Area
Director of Regulatory CMC
Senior Director, Regulatory and Quality Assurance
Director, Regulatory Affairs
Recommendations: 0
Regulatory Submissions
FDA
Clinical Development
GMP
Pharmaceutical Industry
Regulatory Affairs
Biopharmaceuticals
CRO
s****[email protected]
Mary Geissler
Senior Director Regulatory Affairs
Greater Boston Area
Senior Director Regulatory Affairs
Regulatory Affairs
Regulatory Affairs
Regulatory Affairs
Associate Director, Regulatory Affairs
Associate Director, Regulatory Affairs
Associate Director, Regulatory Affairs
Director, Global Regulatory Affairs
Boston University
Saint Michael's College
Recommendations: 0
Regulatory Submissions
Drug Development
Pharmaceutical Industry
Clinical Development
Lifesciences
Regulatory Affairs
IND
FDA
m****[email protected]
Greg Dombal
Chief Operating Officer
Greater Boston Area
Chief Operating Officer
Managing Director
Sr. Director, Regulatory Affairs and Clinical Operations
Director, Regulatory Affairs
Director, Regulatory Affairs
Manager, Regulatory Affairs
Sr. Regulatory Affairs Associate
Regulatory Affairs Associate
University of North Carolina at Chapel Hill
Recommendations: 0
Biotechnology
Clinical Development
Clinical Trials
Pharmaceutical Industry
Regulatory Affairs
Oncology
Lifesciences
FDA
g****[email protected]
Greg Calder
Director, Regulatory Affairs Devices
Greater Boston Area
Director, Regulatory Affairs Devices
Manager Regulatory Affairs
Principal Regulatory Affairs Associate
Manager, Regulatory Affairs
Regulatory Affairs Specialist
Sr. Software and Systems Test Engineer
Northeastern University
Blue Hills Technical Institute
Foxboro High School
Recommendations: 0
Design Control
Medical Devices
Biotechnology
Regulatory Affairs
FDA
Commercialization
CAPA
GMP
g****[email protected]
John Capone
Director, Regulatory Affairs
Greater Boston Area
Director, Regulatory Affairs
Director, Regulatory Affairs & Quality Assurance
Director, Regulatory Affairs
Director, Regulatory Affairs
University of Massachusetts at Lowell
Recommendations: 0
Quality Assurance
Regulatory Affairs
FDA
ISO 13485
Medical Devices
ISO 14971
Quality System
CE marking
j****[email protected]
Denise Oppermann
Associate Director, Regulatory Affairs
Greater Boston Area
Associate Director, Regulatory Affairs
Director, Regulatory Affairs
Senior Director, Regulatory Affairs - Devices
Senior Director, Regulatory Affairs
University of South Florida
Recommendations: 0
Regulatory Affairs
Medical Devices
d****[email protected]
Denisa RAC
Director, Regulatory Affairs Oncology
Greater Boston Area
Director, Regulatory Affairs Oncology
Sr. Associate Director, Regulatory Affairs Oncology
Manager, Regulatory Affairs
Regulatory Affairs Contractor
Regulatory Affairs Intern
Regis College
UMass Boston
Recommendations: 0
d****[email protected]
Christina (DiTomasso)
Senior Study Coordinator
Greater Boston Area
Senior Study Coordinator
Senior Compliance and Regulatory Affairs Specialist
Study Coordinator
Senior Director, Regulatory Affairs
Manager, Regulatory Affairs
Manager, IRB
Principal Consultant
Associate Director, Regulatory Affairs
Director, Regulatory Affairs
Director, Regulatory Affairs (contractor)
Massachusetts College of Pharmacy and Health Sciences
Northeastern University
Recommendations: 0
Regulatory Submissions
Regulatory Affairs
IND
eCTD
FDA
Pharmaceutical Industry
Clinical Trials
Clinical Development
d****[email protected]
c****[email protected]
Mark RAC
Laboratory Assistant
Greater Boston Area
Laboratory Assistant
Clinical Safety Associate
Manager, Regulatory Affairs
Director, Regulatory Affairs
Associate Director, Regulatory Affairs
Sr. Regulatory Affairs Associate
Documentation Assistant
QA Documentation Specialist II
Sr. Regulatory Affairs Associate
Regis College
Western State Colorado University
Recommendations: 0
Sop
Regulatory Affairs
GMP
Clinical Trials
FDA
Regulatory Submissions
m****[email protected]
Emily VanHassel
Senior Director, Regulatory Affairs CMC
Greater Boston Area
Senior Director, Regulatory Affairs CMC
Director, Regulatory Affairs CMC
Associate Regulatory Program Director, Pharma Technical Regulatory - Small Molecules Development
Director, Regulatory Affairs CMC
Research Associate, Small Molecules Pharmaceutical Sciences
Research Associate
Senior Associate Scientist, Analytical Sciences
Associate Director of Regulatory Affairs
Carnegie Mellon University
Carnegie Mellon University
Recommendations: 0
Regulatory Affairs
Analytical Chemistry
Biotechnology
Technology Transfer
GMP
GLP
Validation
Drug Development
e****[email protected]
Wei Zhao
Director, Regulatory Affairs
Greater Boston Area
Director, Regulatory Affairs
Manager, Regulatory Affairs
Senior Regulatory Affairs Specialist
Senior Director Regulatory Affairs
Senior Director, Regulatory Affairs&Post Market Surveillance
Design Quality Assurance
Medical Affairs Specialist
Director of International Regulatory Affairs
R&D Senior Scientist
Compliance Remediation Group Leader
Iowa State University University
Beijing Medical University
Recommendations: 0
Design Control
Product registration...
New product development
Risk Management
Clinical Evaluation
FDA Medical Device...
EU MDD
Regulatory due...
w****[email protected]
Sara G.
Associate Director, Regulatory Affairs
Greater Boston Area
Associate Director, Regulatory Affairs
Executive Assistant, Clinical Development
Senior Manager, Regulatory Affairs
Associate Director, Regulatory Affairs
Associate Director, Global Regulatory Affairs
Manager, Regulatory Affairs
Senior Associate, Regulatory Affairs
Tufts University School of Medicine
Boston University School of Medicine
Oberlin College
Recommendations: 0
s****[email protected]
Beverly Fellows
Director, Regulatory Affairs & Quality
Greater Boston Area
Director, Regulatory Affairs & Quality
Recommendations: 0
b****[email protected]
Laura Salazar-Fontana
Director, Regulatory Affairs, CMC
Greater Boston Area
Director, Regulatory Affairs, CMC
Associate Director, Global Regulatory Affairs CMC Biologics
Global Strategic Advisor for Immunology and Biomarkers
Immunogenicity
CMC reviewer (Immunogenicity)
Universidad Autónoma de Madrid
Universidad Autónoma de Madrid
Recommendations: 0
Immunology
Molecular Biology
Cell Biology
Infectious Diseases
Immunogenicity
Risk assessment
Risk mitigation
Regulatory Agencies
l****[email protected]
William JD
Director, CMC Regulatory Science
Greater Boston Area
Director, CMC Regulatory Science
Vice President
Associate Director Regulatory Affairs
Director, Regulatory Affairs
Member of the Calaveras County Air Pollution Control Hearing Board
Member Board Of Directors
Director, CMC Regulatory Science
CMC Regulatory Affairs and Technical Consultant
Director, CMC Regulatory Affairs
University of California, Los Angeles
Taft University
Washington State University
Recommendations: 0
Regulatory Affairs
Drug Development
FDA
Validation
Vaccines
Microbiology
Quality Assurance
Aseptic Processing
w****[email protected]
Rick Shansky
Executive Director, Regulatory Affairs, Global CMC
Greater Boston Area
Executive Director, Regulatory Affairs, Global CMC
Senior Director, Global Head, Regulatory Affairs-CMC
Director, Regulatory Affairs-CMC
Senior Director
Senior QC Scientist
Principal Scientist
Northeastern University
Tufts University
Recommendations: 0
IND
Biopharmaceuticals
Regulatory Submissions
Biotechnology
Technology Transfer
FDA
GMP
Regulatory Affairs
r****[email protected]
Michael Chang
Regulatory Affairs CMC and International (Associate II and Senior Associate)
Greater Boston Area
Regulatory Affairs CMC and International (Associate II and Senior Associate)
Regulatory Affairs Specialist
Regulatory Affairs CMC (Manager and Associate Director)
Director, Regulatory Affairs CMC
Director, Regulatory Affairs CMC
Boston University
Recommendations: 0
m****[email protected]
Kimberly Richard-O'Brien
Senior Director, Regulatory Affairs - Advertising, Labeling and Promotion
Greater Boston Area
Senior Director, Regulatory Affairs - Advertising, Labeling and Promotion
Director, Regulatory Affairs - Advertising Labeling and Promotion - Tecfidera and MS Franchise
Associate Director, Regulatory Affairs - Advertising, Labeling and Promotion
Sr. Manager, Regulatory Affairs - Advertising, Labeling, and Promotion
Manager, Regulatory Affairs - Advertising, Labeling and Promotion
Sr Regulatory Affairs Specialist
Regulatory Affairs
QA Documentation Supervisor
Northeastern University
Northeastern University
Boston University School of Medicine
Boston University
Recommendations: 0
FDA
Biotechnology
IND
Pharmaceutical Industry
Regulatory Submissions
NDA
Clinical Development
Regulatory Affairs
k****[email protected]
Lisa Scaglione
Manager of Regulatory Affairs
Greater Boston Area
Manager of Regulatory Affairs
Head of Regulatory Affairs, IGT BG
Clinical and Regulatory Affairs Associate
AVP, Regulatory Affairs and Quality Compliance
Sr. Director, Regulatory Affairs
Director of Regulatory Affairs
Associate Vice President, Regulatory Affairs
Sr. Director, Regulatory Affairs
VP of Regulatory, Quality, and Clinical Affairs
Lesley University
Northeastern University
Recommendations: 0
l****[email protected]
Janet Kay
Vice President, Regulatory Affairs
Greater Boston Area
Vice President, Regulatory Affairs
Compliance Officer
Sr. Reg Specialist
Senior Regulatory Affairs Specialist
Semi retired
Director Regulatory Affairs
International Regulatory Affairs Manager
Regulatory Affairs Manager
Colleague
Director, Regulatory Affairs
Director, Regulatory Affairs
Cardinal Newman HS
Recommendations: 0
CE marking
ISO 14971
ISO 13485
Design Control
FDA
PMA
Medical Devices
CAPA
j****[email protected]
j*****@k1nu.com
Debbie DeMuria, PharmD
Senior Director, Regulatory Affairs
Greater Boston Area
Senior Director, Regulatory Affairs
Director, Global Regulatory Strategy
Senior Director, Regulatory Affairs
Director, Regulatory Affairs
Senior Regulatory Affairs Associate
Head, Investigational Pharmacy
ACCP Fellow in Pharmacokinetics
Resident, Clinical Pharmacy
Massachusetts College of Pharmacy and Health Sciences
University of Connecticut
Recommendations: 0
Regulatory Affairs
Pharmacokinetics
Pharmacology
Drug Development
Regulatory Submissions
Oncology
IND
Biopharmaceuticals
d****[email protected]
Todd Brill
Regulatory Affairs
Greater Boston Area
Regulatory Affairs
Associate Director, Regulatory Affairs
Vice President, Regulatory Affairs and Quality Assurance
Chief of Staff, Global Regulatory Affairs and R&D Quality
Quality Assurance/Regulatory Affairs
Associate Director, Regulatory Affairs
Surface Warfare Officer
Senior Director, Global Regulatory Affairs and Quality Assurance
Regulatory Affairs Manager
United States Naval Academy
Recommendations: 0
FDA
Medical Devices
Regulatory Affairs
CAPA
Biotechnology
Regulatory Submissions
GMP
Validation
t****[email protected]
AnneMarie Woodland
Executive Director, Quality and Regulatory
Greater Boston Area
Executive Director, Quality and Regulatory
Quality Control Manager
Senior Vice President, Regulatory Affairs and Quality Assurance
Vice President, Regulatory Affairs and Quality Assurance
Executive Director, Regulatory Affairs
Director, Quality
Principal Consultant
Vice President, Regulatory Affairs
Senior Director, Quality
Lesley University
Fitchburg State University
Recommendations: 0
Regulatory Affairs
Quality Assurance
Quality Systems
GxP
Biopharmaceuticals
Clinical Trials
Protein Chemistry
FDA
a****[email protected]
Anu Davies
Head of CMC Regulatory Submissions and Document Compliance, Process Development
Greater Boston Area
Head of CMC Regulatory Submissions and Document Compliance, Process Development
Senior Director, Product Development
Director, Regulatory Affairs
Director Clinical Supplies
Clinical Supplies Manager
Clinical Supplies Team Leader
University of Nottingham
Recommendations: 0
Pharmaceutical Industry
Clinical Development
Regulatory Submissions
Clinical Trials
Drug Development
Regulatory Affairs
Regulatory Requirements
GMP
a****[email protected]
Ann Ferentz
Executive Director, Regulatory Affairs
Greater Boston Area
Executive Director, Regulatory Affairs
Senior Manager, Regulatory Affairs
Manager, Scientific Communications
Associate Director, Regulatory Affairs
Associate Director, Scientific Reporting
Clinical Writing Lead
Fellow
Harvard University
Yale University
Recommendations: 0
Oncology
Pharmaceutical Industry
Regulatory Submissions
IND
Clinical Development
Biotechnology
Clinical Trials
Drug Development
a****[email protected]
Carissa H.
Senior Manager, Regulatory Advertising, Labeling, and Promotion
Greater Boston Area
Senior Manager, Regulatory Advertising, Labeling, and Promotion
Associate Scientist, Medical Communications
Program Director, Commercial Regulatory Affairs
OMNI Business Unit Therapeutic Area Head, Commercial Regulatory Affairs
BioOncology and IMPACT Therapeutic Area Head, Commercial Regulatory Affairs
Senior Associate II, Regulatory Affairs - Advertising, Labeling, and Promotion
Associate Director, Regulatory Affairs - Advertising, Labeling, and Promotion
Staff Pharmacist
BioOncology Therapeutic Area Head, Commercial Regulatory Affairs
Manager, Medical Affairs: Medical Information
Director, Regulatory Affairs - Advertising, Labeling, and Promotion Fellowship
Northeastern University
Northeastern University
Northeastern University
Recommendations: 0
c****[email protected]
Lisa Dattanasio
Associate Director, Regulatory Affairs
Greater Boston Area
Associate Director, Regulatory Affairs
Recommendations: 0
l****[email protected]
Debra Sojka
Executive Director, Regulatory Affairs
Greater Boston Area
Executive Director, Regulatory Affairs
Vice President Regulatory Affairs
Manager
Director
Associate
Associate Director
Vice President Regulatory Affairs
Mass College of Pharmacy
Recommendations: 0
Sop
Pharmaceutical Industry
Biopharmaceuticals
Biotechnology
FDA
Clinical Development
Drug Development
Lifesciences
d****[email protected]
Debra Stamper
Director, Managing Medical Writer
Greater Boston Area
Director, Managing Medical Writer
Director
Manager, Medical Writing
Executive Director, Regulatory Affairs
Senior Manager, Scientific & Medical Communications
Medical Director
Director, Medical Writing
Principal Medical Writer
Executive Director of Medical Writing
Scientific and Medical Communications Consultant
Senior Director, Medical Writing
Global Publications Planning Manager
University of California, Berkeley
Penn State University
University of Colorado
Recommendations: 0
Medical Writing
Publication Planning
Manuscript
Publications
Medical Communications
Manuscript Development
Clinical Development
Infectious Diseases
d****[email protected]
d****[email protected]
Katie Kane
Manager Regulatory Affairs
Greater Boston Area
Manager Regulatory Affairs
Regulatory and Clinical Consultant
Regulatory Affairs Manager
Regulatory Affairs Associate
Director, Regulatory Affairs and Clinical Operations
Associate Director, Regulatory Affairs
Regulatory Affairs
Regulatory Consultant
Boston College
Recommendations: 0
Biotechnology
FDA
Regulatory Affairs
GMP
Clinical Development
Regulations
Pharmaceutical Industry
Drug Development
k****[email protected]
Michael Poirier
Senior Vice President
Greater Boston Area
Senior Vice President
Senior Vice President, Regulatory Affairs
Vice President
Senior Director, Regulatory Affairs
Regulatory Affairs Consultant
Recommendations: 0
Biopharmaceuticals
Biotechnology
IND
Pharmaceutical Industry
Clinical Development
Drug Development
FDA
Regulatory Affairs
m****[email protected]
Nikki Foeller
Senior Marketing Associate/Promotional Materials Review Team Coordinator
Greater Boston Area
Senior Marketing Associate/Promotional Materials Review Team Coordinator
Senior Manager, Regulatory Affairs Advertising and Promotion
Sourcing Associate
Graphic Designer
Associate Director, Regulatory Affairs Labeling and Promotional Integrity
Senior Director, Regulatory Affairs Labeling, Promotion and Operations
Director, Regulatory Affairs Labeling, Promotion and Operations
Graphic Designer
Medical Affairs Associate
Manager, Global Regulatory Affairs Promotion and Advertising
Youngstown State University
The University of Toledo
Recommendations: 0
Pharmaceutical Industry
Pharmaceutical Sales
Oncology
Cross-functional Team Leadership
FDA
Regulatory Affairs
Strategy
Sop
n*****@foeller.org
Christine Vietz
Director of Laboratory Operations
Greater Boston Area
Director of Laboratory Operations
VP, Head of Regulatory Affairs
Associate Director, SearchLight Technical Support
Technical Operations Manager
Director of Quality Assurance
Sr. Director, Regulatory Affairs
SVP, Product Development
Director of Technical Operations
Senior Research Scientist
Associate Director, QA
University of Rochester
University of Rochester
Recommendations: 0
Molecular Biology
Laboratory
Validation
Cell Culture
ELISA
Assay Development
Immunoassays
Sop
c****[email protected]
Donna Gardner
VP Regulatory Affairs
Greater Boston Area
VP Regulatory Affairs
Director, Regulatory Affairs
Recommendations: 0
g****[email protected]
Jilla Boulas
Director, Regulatory Affairs, CMC Strategy
Greater Boston Area
Director, Regulatory Affairs, CMC Strategy
Sr.Regulatory Affairs Consultant
Director, CMC
Sr. Specialist II, Regulatory Affairs
Manager, Regulatory Affairs
Sr. Quality Assurance Specialist
Portland State University
Seattle University
Recommendations: 0
GMP
Regulatory Affairs
FDA
GLP
Biotechnology
Validation
Pharmaceutical Industry
Technology Transfer
j****[email protected]
Paul Beninger
Assistant Professor
Greater Boston Area
Assistant Professor
Vice President, Global Patient Safety
Senior Director, Clinical Risk Management
Director, Medical Services
Director, Regulatory Affairs
Director, Division of General Devices, CDRH
Acting Deputy Director, Division Antiviral Drug Products, CDER
Tufts University
Saint Joseph's University - Erivan K. Haub School of Business
University of California, Davis - School of Medicine
Claremont McKenna College
Recommendations: 0
Infectious Diseases
Vaccines
Regulatory Affairs
FDA
Pharmacovigilance
Diabetes
Cancer
Medical Devices
p****[email protected]
p****[email protected]
Regina Shih
Sr. RA Director, North Asia
Greater Boston Area
Sr. RA Director, North Asia
Vice President, Global Quality and Regulatory Affairs
Director of Regulatory Affairs
Senior Manager of Regulatory Affairs
Director, Regulatory Affairs
Project Manager, Regulatory Affairs
Director, Regulatory Affairs
Vice President Regulatory Affairs
Senior Director, RA/QA, North Asia
Vice President, Quality & Regulatory Affairs
Director, Regulatory Affairs
Manager, Regulatory Affairs
Penn State University
University of Florida
University of Massachusetts Dartmouth
Recommendations: 0
j****[email protected]
Doug Owen
Director, Regulatory Affairs
Greater Boston Area
Director, Regulatory Affairs
Recommendations: 0
d****[email protected]
Christine Regan
Associate Director, Regulatory Affairs
Greater Boston Area
Associate Director, Regulatory Affairs
Associate Director, Corporate Drug Compliance
Senior Director, Regulatory Affairs
Associate Director, Regulatory Affairs
Manager, Regulatory Affairs
Recommendations: 0
EDC
FDA
Regulatory Affairs
Biotechnology
IND
GCP
Pharmaceutical Industry
Regulatory Submissions
c****[email protected]
Terry Moore
Director, Quality Assurance
Greater Boston Area
Director, Quality Assurance
Director, CMC Regulatory Affairs
Sr. Director, Quality Assurance
Sr. Director, Regulatory Affairs
Director, Quality
Director, Quality Assurance
QA Manager
Northeastern University
Susquehanna University
Recommendations: 0
CAPA
Quality System
GMP
FDA
Pharmaceutical Industry
Biotechnology
Quality Assurance
Change Control
t****[email protected]
Marie Minassian
Associate - Manager - Consultant, Regulatory Affairs
Greater Boston Area
Associate - Manager - Consultant, Regulatory Affairs
Manager, US Regulatory Lead
AD, Global Regulatory Lead
Consultant
Consultant, Regulatory Affairs & Drug Safety
AD, Regulatory Program Lead
AD, Global Regulatory Lead
Director, Regulatory Affairs
Pharmacist Assistant
Manager, Drug Safety
Lycee Chaptal
Lycee International
Universite de Geneve
Recommendations: 0
Aaron RAC
Senior Consultant, Regulatory Affairs
Greater Boston Area
Senior Consultant, Regulatory Affairs
Director of Regulatory Affairs
Director of Regulatory Affairs
Director, Regulatory Affairs and Quality
Global Director, Regulatory Affairs and Project Management
Dalhousie University Law/Pharmacy School
Northeastern University
Rutgers, The State University of New Jersey-Newark
Recommendations: 0
Lee Houston
Regulatory Affairs Manager
Greater Boston Area
Regulatory Affairs Manager
Associate Director, Regulatory Affairs
Regulatory Affairs Coordinator
Regulatory Affairs Senior Manager
Sr Regulatory Affairs Associate
Sr Regulatory Affairs Associate
Associate Project Manager
Regulatory Affairs Manager
University of California, Los Angeles
University of Dayton
Recommendations: 0
Kaity Posada
Clinical Research Scientist
Greater Boston Area
Clinical Research Scientist
Director Clinical Development
Sr Director
Sr Director
Director, Global Regulatory Affairs
Director Regulatory Affairs
Assistant Director Clinical Development
Sr Clinical Research Scientist
Postdoctoral Fellow
Sr Director Regulatory Affairs
Postdoctoral Fellow
Director, Regulatory Affairs
Associate Director Clinical Decelopment
Rutgers College of Pharmacy
Bridgewater-Raritan High School
Recommendations: 0
Biotechnology
CRO
Clinical Development
Clinical Trials
Drug Development
FDA
GCP
Pharmaceutical Industry
Martin RAC
Director, Regulatory Affairs
Greater Boston Area
Director, Regulatory Affairs
Associate Director, Regulatory Affairs
CDER: Division of Pyschiatry Products (DPP)
Manager, Regulatory Affairs
Clinical Trial Processing Lab
CDER: Division of Monoclonal Antibodies
Regulatory Affairs/Safety and Benefit-Risk Management
Senior Manager, Regulatory Affairs
James Anticoagulation Management Service
The Ohio State University
The Ohio State University
Recommendations: 0
Mark FRAPS
Vice President, Head of Global Regulatory Affairs
Greater Boston Area
Vice President, Head of Global Regulatory Affairs
Post-doctoral Fellow
Vice President, Regulatory Drugs/Biologics & Head, US Operations
Director, Regulatory Affairs
Chief Regulatory Officer
Associate Director, Product Development
Research Chemist
Senior Vice President, Regulatory Affairs, Quality Assurance, and CMC
Regulatory Consultant
Senior Director, Global Clinical Regulatory Strategy
Senior Vice President, Regulatory Affairs and Quality Assurance
Associate Director, Regulatory Affairs
University of California, San Diego
University of Wisconsin-Parkside
Recommendations: 0
MaryLou Stroumbos
Regulatory Affairs Manager
Greater Boston Area
Regulatory Affairs Manager
Marketing Communicatons Manager
Marketing Communications Manager
Executive Vice President Regulatory Affairs & Quality Assurance
Vice President Regulatory Affairs & Quality Assurance
Director, Regulatory Affairs
Director Regulatory Affairs
Suffolk University Law School
Rivier University
University of Massachusetts at Lowell
Recommendations: 0
Medical Devices
Regulatory Affairs
Regulatory Submissions
FDA
ISO 13485
CAPA
GMP
Design Control
Katherine Marshall McNeal
Director, Advertising & Promotion Regulatory Affairs
Greater Boston Area
Director, Advertising & Promotion Regulatory Affairs
Director, Regulatory Affairs, Advertising & Promotion
Associate Director, Regulatory Affairs
Senior Regulatory Manager
Senior Scientist / Regulatory Affairs Manager
Associate Scientist / Scientist; Clinical Quality Assurance Auditor
Associate Scientist, Clinical Research Associate
Associate Scientist, Pharmacovigilance
Clinical Supervisor, Infection Control/QA and Risk Management
University of Cincinnati
Recommendations: 0
Pharmaceutical Industry
Regulatory Advertising & Promotion
Clinical Trials
Sop
Clinical Quality Assurance
Clinical Research
Regulatory Affairs - post-market support
Pharmacovigilance
