Top Manager, Regulatory Affairs in Greater Boston Area
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]
Elaine Lowell
Product Owner, Clinical Application Development & Technologies
Greater Boston Area
Product Owner, Clinical Application Development & Technologies
Principal Business Analyst, Clinical Application Development Technology
Sr. Business Analyst, Clinical Research Services, Corporate PMO
Principal Consultant
Consultant
Clinical Trial Consultant
Sr Business Analyst
Regulatory Writer
Policy and Procedure Writer
Consultant
GCP Consultant
Manager, Clinical Operations
Manager, Regulatory Affairs
Knowledge Analyst
Information Specialist
Information Specialist
Fairleigh Dickinson University
University at Buffalo
State University of New York College at Geneseo
University of Massachusetts at Lowell
Recommendations: 3
Healthcare IT
Organizational Analysis
Business Process Improvement
Business Process Mapping
Business Analysis
Training
SDLC
Functional Specifications
l****[email protected]
e****[email protected]
Helen DABT
Drug Safety Team Lead, Associate Research Fellow
Greater Boston Area
Drug Safety Team Lead, Associate Research Fellow
Manager, Regulatory Affairs
Principal Investigator— safety pharmacology, Toxicology Study Director/Monitor, Roche Palo Alto
Toxicologist, Associate Director
Toxicologist, Principal Scientist
Toxicology Study Director/Study Monitor, Early Safety Representative, Roche Nutley
Michigan State University
China Pharmaceutical University
Recommendations: 2
In Vitro
Drug Discovery
In Vivo
Pharmacology
Toxicology
Drug Development
Pharmaceutical Industry
Clinical Development
w****[email protected]
Michael Doyle
Director, Medical Device Regulatory, CMC
Greater Boston Area
Director, Medical Device Regulatory, CMC
Global Director Regulatory Affairs & Quality Assurance
Director of Regulatory & Clinical Affairs
Manager, Regulatory Affairs
Sr. Regulatory Affairs Specialist
Sr. Quality Engineer
Wentworth Institute of Technology
Recommendations: 2
ISO 13485
FDA
Design Control
Regulatory Submissions
Regulatory Affairs
Medical Devices
ISO 14971
Cross-functional Team...
m****[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]
Laura Howson
Sr Manager, Regulatory Affairs CMC
Greater Boston Area
Sr Manager, Regulatory Affairs CMC
Manager, Regulatory Affairs CMC
Manager, Regulatory Affairs
Sr Regulatory Affairs Specialist
Staff CMC Regulatory Writer/Sr CMC Regulatory Writer
Chemist/Staff Biochemist
Saint Joseph's University
Temple University
Haverford College
Madison High School
Recommendations: 1
Regulatory Affairs
Regulatory Submissions
FDA
Vaccines
GMP
IND
Biologics
Regulatory Requirements
l****[email protected]
Kiley Mitrano
Principal Consultant, Regulatory Affairs
Greater Boston Area
Principal Consultant, Regulatory Affairs
Regulatory Affairs Associate II
Associate Director Regulatory Affairs
Clinical Trials Associate
Senior Regulatory Affairs Associate
Regulatory Affairs Associate I
Senior Manager, Regulatory Affairs
Regulatory Affairs Associate II
Recommendations: 1
Regulatory Affairs
Pharmaceutical Industry
Training
FDA
Clinical Trials
Clinical Development
Drug Development
eCTD
k****[email protected]
David Hymes
Regulatory Affairs Associate
Greater Boston Area
Regulatory Affairs Associate
Regulatory Affairs Associate
Manager, Regulatory Affairs
Director Regulatory Affairs
Principal Consultant
Associate Director
Director Regulatory Affairs
Associate Director
Sr. Manager, Regulatory Affairs
Connecticut College
Massachusetts College of Pharmacy and Health Sciences
Wesleyan University
Recommendations: 1
IND
Regulatory Affairs
Drug Development
Biologics
Regulations
Pharmaceutical Industry
Clinical Research
eCTD
d****[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
Sarah Fairfield
Senior Manager Regulatory Affairs
Greater Boston Area
Senior Manager Regulatory Affairs
Regulatory Affairs Specialist
Student Researcher
Senior Regulatory Affairs Specialist
Principal Regulatory Affairs Specialist
Regulatory Affairs Advisor
Process Engineer
Manager, Regulatory Affairs
Regulatory Affairs Specialist
Simmons College - Simmons School of Management
Purdue University
Recommendations: 1
Medical Devices
V&V
Regulatory Affairs
Regulatory Submissions
Clinical Research
Design Control
FDA
PMA
s****[email protected]
Kandarp RAC
Manager, Regulatory Affairs
Greater Boston Area
Manager, Regulatory Affairs
Senior Regulatory Affairs Associate (Contractor through BioBridges)
Regulatory Affairs Associate
MS in Regulatory Affairs for Drugs, Biologics and Medical devices
Intern Clinical Pharmacist (Clinical Pharmacy Practice Experience)
Quality and Compliance
Northeastern University
Institute of Pharmacy, Nirma University
Institute of Pharmacy, Nirma University
Recommendations: 1
NDA
Regulatory Affairs
Drug Development
GMP
IND
Sop
Validation
Medical Devices
p****[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]
Perrine Geoffroy
Clinical Pharmacy Student
Greater Boston Area
Clinical Pharmacy Student
Regulatory Affairs Co-op
Manager, Regulatory Affairs
Senior Manager, Regulatory Affairs
Regulatory Affairs and Quality Assurance - Trainee
Regulatory Affairs Consultant - Intern
Director, Regulatory Science
Sr Associate II, Regulatory Affairs
Intern in Biology Laboratory
Associate Director, Regulatory Science
Northeastern University
Paris-Sud University (Paris XI)
Université Claude Bernard (Lyon I)
Recommendations: 0
Regulatory Affairs
Pharmaceutical Industry
g****[email protected]
p****[email protected]
Kevin Whetstone
Associate Director, Regulatory
Greater Boston Area
Associate Director, Regulatory
Senior Manager, Regulatory Operations
Regulatory Contractor
Manager, Regulatory Affairs
Manager, Regulatory
Document Coordinator
Team Manager
Regulatory Operations
Document Specialist
Commerce
Recommendations: 0
Regulatory Affairs
Biotechnology
Clinical Trials
Sop
Pharmaceutical Industry
FDA
Regulatory Submissions
21 CFR Part 11
k****[email protected]
Shruta Ph.D.
Research Scientist
Greater Boston Area
Research Scientist
Director, Global Regulatory Affairs
Clinical Research Scientist
Global Regulatory Affairs, Vertex
Vice President, Head of Global Regulatory Affairs and Pharmacovigilance Operations
Manager, Regulatory Affairs
Senior Clinical Research Scientist
Associate Director, Global Regulatory Affairs
Bowling Green State University
KEM Hospital
Recommendations: 0
Regulatory Strategy
Regulatory Submissions
Clinical Development
Clinical Trials
Pharmaceutical Industry
Clinical Research
IND
GCP
s****[email protected]
Jennifer Callahan
Sr. Manager, Regulatory Affairs
Greater Boston Area
Sr. Manager, Regulatory Affairs
Manager, Regulatory Global Clinical Trials
Regulatory Affairs
Sr. Regulatory Associate, Global Clinical Trials
Associate II, Regulatory Affairs
Associate I, Regulatory Affairs
Documentation Coordinator, Regulatory Affairs
Regulatory Documentation Specialist
N/A
Recommendations: 0
Pharmaceutical Industry
Biotechnology
FDA
Sop
Regulatory Affairs
Clinical Trials
GMP
IND
j****[email protected]
j****[email protected]
Fusun Hande Tufan
Sr. Consultant, Regulatory Affairs
Greater Boston Area
Sr. Consultant, Regulatory Affairs
Senior Manager Regulatory Affairs
Manager, Regulatory Affairs
Regulatory Affairs Project Manager
Sr. RA Specialist
San Diego State University-California State University
Boğaziçi University
Recommendations: 0
Regulatory Affairs
Medical Devices
Quality Systems
FDA
ISO 13485
510 K
Life Sciences
Regulatory Strategy
h****[email protected]
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]
Tara Reed
Manager, Regulatory Affairs
Greater Boston Area
Manager, Regulatory Affairs
QA Specialist
Senior Associate, Regulatory Affairs
Research Technician
Associate Manager, Pharmacology/Toxicology
Research Associate, Pharmacology/Toxicology/Immunology
Intern, Discovery Biology
Senior Manager, Regulatory Affairs
Associate, Regulatory Affairs
Massachusetts College of Pharmacy and Health Sciences
Providence College
Masconomet
Recommendations: 0
t****[email protected]
Stephanie Melillo Fradette
Senior Manager, Regulatory Affairs
Greater Boston Area
Senior Manager, Regulatory Affairs
Manager, Regulatory Affairs
Senior Associate II, Regulatory Affairs
Pharmacist
Post Doctoral Fellow
Research Assistant
Northeastern University
Recommendations: 0
s****[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]
Rumi RAC
Global Regulatory Lead (Immuno-oncology), Global Regulatory Strategy
Greater Boston Area
Global Regulatory Lead (Immuno-oncology), Global Regulatory Strategy
Manager, Regulatory Affairs North America
Manager, Regulatory Affairs North America
Senior Associate - US Regulatory Affairs
Senior Associate - Global Regulatory Strategy
Global Quality and Compliance Associate (Intern)
Northeastern University - College of Professional Studies
University of Pune
Recommendations: 0
510 K
IND
ANDA
CE marking
IRB
Regulatory Submissions
Medical Devices
GLP
d****[email protected]
Danielle (Rondeau) Pelletier, MSRA RAC
Global Regulatory Intelligence, Policy & Training, Global Regulatory Affairs & Compliance
Greater Boston Area
Global Regulatory Intelligence, Policy & Training, Global Regulatory Affairs & Compliance
Manager, Strategy & Submissions, Global Regulatory Affairs
Commercial Litigation Paralegal
Research Assistant
Development Assistant
Environmental Legal Assistant Co-op
Teaching Assistant & Tutor for Statistical Analysis in Sociology
Restaurant Accountant
Manger, Regulatory Affairs
Team Leader
Senior Manager, Regulatory Affairs
Northeastern University
Northeastern University
Suffolk University
Recommendations: 0
Access
Research
Data Entry
Leadership
Customer Service
Public Speaking
Human Resources
Strategy
r****[email protected]
Michelle Godin
Sr Manager, Pathology
Greater Boston Area
Sr Manager, Pathology
Project Leader, RA, Neuroscience
Sr Project Manager
Associate Director, RA
Project Manager, Regulatory Affairs
Sr Manager, Regulatory Affairs
Manager, RA, Neurovascular
Senior Manager, Regulatory Affairs
Towson University
Hood College
Recommendations: 0
CRO
GLP
FDA
Medical Devices
IND
Drug Development
ISO 13485
Quality System
m****[email protected]
Kathy Andrade
Senior Manager
Greater Boston Area
Senior Manager
Regulatory Affairs Manager
Manager Regulatory Affairs
Manager Regulatory Affairs
Sr. Associate Regulatory Affairs
Manager, Regulatory Affairs
Harvard University
University of Massachusetts Boston
Recommendations: 0
Regulatory Strategy
Medical Devices
Strategy
Biotechnology
Regulatory Submissions
Clinical Trials
Pharmaceutical Industry
Regulatory Affairs
k****[email protected]
Angela Neufeld
Manager, Regulatory Affairs
Greater Boston Area
Manager, Regulatory Affairs
Sr. Associate, Regulatory Affairs
Senior Manager Regulatory Affairs
Senior Manager
Associate Director Regulatory Affairs
Regulatory Affairs Associate
Director, Global Regulatory Sciences
Massachusetts College of Pharmacy and Health Sciences
Wheaton College (MA)
Recommendations: 0
c****[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]
Robert Lavado
Solutions Engineer
Greater Boston Area
Solutions Engineer
Manager, Regulatory Affairs
Sr. Manager, Regulatory Affairs
Sr. Regulatory Affairs Specialist
Regulatory Affairs Specialist II
Worcester Polytechnic Institute
Worcester Polytechnic Institute
Recommendations: 0
Medical Devices
FDA
ISO 13485
Regulatory Affairs
Design Control
CAPA
Quality System
Design of Experiments
r****[email protected]
r****[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]
Michelle O'Brien
Associate Director Regulatory Affairs
Greater Boston Area
Associate Director Regulatory Affairs
Senior Manager, Regulatory Affairs
Senior Manager, Quality Assurance
Quality Assurance Manager
Manger, Quality Assurance
Boston University
Recommendations: 0
GMP
CAPA
FDA
Validation
Change Control
Pharmaceutical Industry
GxP
Quality Assurance
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]
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]
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
Virginia RAC
Associate Director - Global Regulatory Lead, Global Regulatory Affairs, Immuno-Oncology
Greater Boston Area
Associate Director - Global Regulatory Lead, Global Regulatory Affairs, Immuno-Oncology
Manager, Regulatory Affairs
Senior Regulatory Affairs Specialist
Regulatory Affairs Specialist
Quality Microbiologist
University of New Hampshire
Nashua
Recommendations: 0
PMA
FDA
ISO 13485
Regulatory Affairs
Design Control
Medical Devices
ISO
Clinical Trials
v****[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]
Donald Holloran
Contract - Regulatory Affairs Project Manager
Greater Boston Area
Contract - Regulatory Affairs Project Manager
Regulatory Affairs Specialist III
Sr. Regulatory Affairs Associate
Associate Director, Regulatory, Quality and Compliance
Associate Manager, Regulatory Affairs
Associate Director Regulatory Affairs
Contract - Global Project Manager Regulatory Affairs
Salem State University
Recommendations: 0
Regulatory Affairs
Pharmaceutics
Biologics
Biopharmaceuticals
Combination Products
Regulatory Submissions
Project Management
Cross-functional Team Leadership
d****[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]
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]
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]
Mark Puopolo
Head of Quality Assurance and Regulatory Affairs
Greater Boston Area
Head of Quality Assurance and Regulatory Affairs
Head of Quality Assurance
Director of Quality Assurance and Regulatory Affairs/Management Representative
Associate Director, Regulatory Affairs/Head of RA
Senior Manager, Regulatory Affairs
Manager of Quality Assurance and Regulatory Affairs
Worcester Polytechnic Institute
Worcester Polytechnic Institute
Worcester Polytechnic Institute
Recommendations: 0
ISO 13485
Medical Devices
Design Control
FDA
CAPA
Quality System
Regulatory Affairs
CE marking
m****[email protected]
Sarah Feathers
Director, Global Regulatory Lead
Greater Boston Area
Director, Global Regulatory Lead
Manager, Regulatory Affairs, Area & Affiliate Strategy
Managed Care Rotation Experience (PharmD Candidate)
Advanced Institutional Rotation Experience (PharmD Candidate)
Advertising & Promotion Intern
Global Medical Review (PharmD PDP)
Pharmacy Intern
Acute Care Rotation Experience (PharmD Candidate)
Director, Global Regulatory Affairs, Oncology
Industry Rotation Experience (PharmD Candidate)
Global Medical Information (PharmD PDP)
Ambulatory Care Rotation Experience (PharmD Candidate)
The George Washington University
West Virginia University School of Pharmacy
Recommendations: 0
s****[email protected]
Janaki Subramanyam
Senior DIrector, Regulatory Affairs
Greater Boston Area
Senior DIrector, Regulatory Affairs
Senior Director, Global Regulatory Affairs
Director, Global Regulatory Affairs
Manager, Regulatory Affairs
Ohio University
St. Xavier's College
Recommendations: 0
Clinical Development
Regulatory Affairs
Pharmacovigilance
Clinical Trials
Sop
Pharmaceutical Industry
Oncology
CRO
j****[email protected]
claudia panska
Senior Manager Regulatory Affairs
Greater Boston Area
Senior Manager Regulatory Affairs
Regulatory Coordinator
Regulatory Affairs Associate
Manager, Regulatory Affairs
Associate Director, Regulatory Affairs at Epizyme
Senior Regulatory Specialist
Regis College
Recommendations: 0
c****[email protected]
c****[email protected]
Keri Stella
Various positions within Clinical Operations
Greater Boston Area
Various positions within Clinical Operations
Manager, Regulatory Affairs
Associate Director, Regulatory Affairs, Advertising and Promotion
Director of Regulatory Affairs, Advertising and Promotion
Sr. Contracts Manager
Sr. Contracts Manager, Clinical Contracting&Outsourcing
Senior Manager, Regulatory Affairs, Advertising, Labeling and Promotion
Suffolk University - Sawyer School of Management
The University of Kansas
Andover High School
Recommendations: 0
Clinical Trials
Biotechnology
Clinical Development
IND
FDA
Regulatory Affairs
Regulatory Submissions
GCP
k****[email protected]
Brooke Hinkson
Head Global Clinical Data Standards
Greater Boston Area
Head Global Clinical Data Standards
Associate Director Program Management
Data Manager
Project Manager
Project Manager, E-Services, Advanced Technologies and Informatics Group
Global Head, Clinical Information Governance, Clinical Sciences & Operations
Director, R&D IS
Manager, Regulatory Affairs
Wheaton College Massachusetts
Recommendations: 0
Clinical Trials
Process Improvement
Program Management
Strategic Planning
Clinical Development
Business Strategy
Biotechnology
Healthcare
b****[email protected]
b****[email protected]
Michael Mulholland
Manager, Regulatory Affairs
Greater Boston Area
Manager, Regulatory Affairs
Senior Manager, Regulatory Affairs
Manager, Regulatory Affairs
CDDS Project Manager
Manager, Regulatory Affairs
Recommendations: 0
Clinical Trials
Regulatory Affairs
Biotechnology
21 CFR Part 11
Clinical Development
FDA
Pharmaceutical Industry
Regulatory Submissions
m****[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]
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]
Patti Maguire
Senior Manager, Regulatory Affairs
Greater Boston Area
Senior Manager, Regulatory Affairs
Senior Regulatory Affairs Associate
Regulatory Affairs Associate II
Regulatory Affairs Contractor
Temporary Support Staff
Manager, Regulatory Affairs
Harvard University
Recommendations: 0
Regulatory Affairs
Medical Devices
Biotechnology
Research
Proofreading
Editing
Lifesciences
Sop
m****[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]
Amelia H.
Senior Manager, Regulatory Affairs - Devices
Greater Boston Area
Senior Manager, Regulatory Affairs - Devices
Manager, Regulatory Affairs - Devices
Regulatory Affairs Manager
Sr. Regulatory Affairs Specialist
Global Regulatory Affairs Specialist
Rochester Institute of Technology
Rochester Institute of Technology
Recommendations: 0
Medical Devices
Regulatory Affairs
Technical Files
Standards Compliance
Regulatory Submissions
Regulatory Strategy
510 K
FDA
a****[email protected]
Danielle Farinato
Manager, Regulatory Affairs-CMC
Greater Boston Area
Manager, Regulatory Affairs-CMC
Sr. Quality Associate, Supply Chain Quality
Associate Scientist, Cell Culture Process Development
Manufacturing Associate, Development Engineering/Process Biochemistry
Tufts University
Boston University
Recommendations: 0
d****[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]
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]
Preeti Singh
Global Regulatory Affairs
Greater Boston Area
Global Regulatory Affairs
Global Labeling Lead
Manager, Regulatory Affairs
Associate, Regulatory Affairs
Associate, Regulatory Affairs
Hibernia College
Regulatory Affairs Professionals Society
McGill University
Concordia University
Recommendations: 0
Regulatory Submissions
Regulatory Affairs
FDA
Pharmacovigilance
Clinical Trials
Pharmaceutical Industry
Change Control
p****[email protected]
Swetha RAC
Manager, Regulatory Submissions Management
Greater Boston Area
Manager, Regulatory Submissions Management
Project Manager Regulatory Affairs (EPD)
Manager, Regulatory Submissions Management
Submission Project Manager, Regulatory Affairs
Submission Project Manager
Regulatory Associate
Regulatory Affairs Publishing Specialist
Senior Manager, Regulatory Publishing
Submission Project Manager
Sullivan University
Northeastern University
Osmania University
Recommendations: 0
s****[email protected]
Margaret Brancolino
Principal and Consultant
Greater Boston Area
Principal and Consultant
Associate Director
Associate Manager, Regulatory Affairs
Sr. Manager Regulatory Affairs - Labeling
Labeling Manager
Associate Manager, Regulatory Affairs
Regulatory Affairs Specialist
University of South Florida
Recommendations: 0
m****[email protected]
Tom Mullins
Principle Consultant
Greater Boston Area
Principle Consultant
Manager, Regulatory Affairs
Senior Regulatory Affairs Associate
Supervisor, Quality Assurance Documentation
Northeastern University
Recommendations: 0
Clinical Trials
Pharmaceutics
FDA
CAPA
GMP
Clinical Development
Change Control
Technology Transfer
t****[email protected]
Dipali MS
Regulatory Affairs Consultant
Greater Boston Area
Regulatory Affairs Consultant
Senior Associate, Regulatory Affairs
Regulatory Affairs Officer
Associate Manager, Regulatory Affairs
Pharmacist
Senior Specialist, Regulatory Affairs
Graduate Teaching Assistant
Massachusetts College of Pharmacy and Health Sciences
Dr.L.H.Hiranandani College Of Pharmacy, Mumbai
NCRD's Institute Of Pharmacy, Mumbai
Recommendations: 0
d****[email protected]
Randy Covill
Manager, Regulatory Affairs
Greater Boston Area
Manager, Regulatory Affairs
Manager Regulatory Affairs
Senior Change Control Specialist
Vaidation Specialist
Validation Specialist
Temple University
Boston University - Metropolitan College
Southern New Hampshire University
Recommendations: 0
r****[email protected]
Adam Mercer
Manager, Strategy & Change Management Consulting
Greater Boston Area
Manager, Strategy & Change Management Consulting
Product Management Intern
Senior Consultant
Litigation Support Specialist
Manager, Regulatory Affairs
Babson College - Franklin W. Olin Graduate School of Business
Duke University
Recommendations: 0
Project Management
Business Strategy
Program Management
Business Analysis
Strategic Planning
Consulting
Market Research
Cross-functional Team Leadership
a****[email protected]
a*****@alumni.duke.edu
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]
Marybeth Gamber
Manager Regulatory Affairs
Greater Boston Area
Manager Regulatory Affairs
Regulatory and Quality Affairs Specialist
Principal Regulatory Affairs Specialist
Executive Director, Regulatory Affairs & Quality
Director Regulatory Affairs
VP Regulatory Affairs, Compliance, and Quality
Regulatory Affairs Consultant, Medical Devices
Manager, Regulatory Affairs
Recommendations: 0
V&V
FDA
Regulations
Regulatory Affairs
Biomedical Engineering
CAPA
ISO 13485
Design Control
m****[email protected]
m****[email protected]
Mary LeGraw
Principal Consultant, Regulatory Affairs
Greater Boston Area
Principal Consultant, Regulatory Affairs
VP Regulatory Affairs
Regulatory Consultant
VP Regulatory Affairs
V.P. Regulatory Affairs
Manager, Regulatory Affairs
Recommendations: 0
Interventional Radiology
Vascular
Regulatory Affairs
FDA
Medical Devices
ISO 14971
CAPA
PMA
l****[email protected]
Gloria Imperial
Associate Director Regulatory Affairs - CMC
Greater Boston Area
Associate Director Regulatory Affairs - CMC
Manager, Global Regulatory Affairs
Manager, Regulatory Affairs
Regulatory Affairs Manager
Regulatory Affairs, Project Leader
Senior Associate, Regulatory Affairs
University of Waterloo
Recommendations: 0
Regulatory Affairs
FDA
Regulatory Submissions
Pharmaceutical Industry
eCTD
GMP
Sop
Regulatory Requirements
g****[email protected]
Brian M.S.
Pfizer Library Research Assistant
Greater Boston Area
Pfizer Library Research Assistant
Regulatory CMC Manager
Manager, Regulatory Affairs CMC
Senior Associate, Global Regulatory Affairs CMC Devices
QC Analyst
Associate II, Global Regulatory Affairs CMC Devices
Stability Specialist Associate
Stability Specialist
Compliance Specialist Senior
Senior Manager, CMC Regulatory Affairs
Massachusetts College of Pharmacy and Health Sciences
San Diego State University-California State University
University of Connecticut
Recommendations: 0
cGMP
Quality Assurance
Data Analysis
Microsoft Office
Excel
PowerPoint
LIMS
GMP
b****[email protected]
Annie Neild
Director of Regulatory Affairs
Greater Boston Area
Director of Regulatory Affairs
Director
Medical Writer
Senior Medical Writer
Manager, Regulatory Affairs
Director Global Regulatory Affairs
Sr. Manager, Regulatory Affairs
Director
Manager, Clinical Research
Associate Director Regulatory Affairs
Director Global Regulatory Affairs
Post Doc
Manager, Medical Writing and Publications
Yale University
tufts csdd
tufts csdd
Recommendations: 0
Clinical Development
Medicine
Infectious Diseases
Medical Writing
Clinical Research
Biotechnology
Pharmaceutical Industry
Immunology
a****[email protected]
a****[email protected]
Sue FRAPS
President
Greater Boston Area
President
Regulatory Affairs Manager
Past Chair
Director of Quality
Chair Boston Chapter
Retired
Retired
RAPS Fellow
Regulatory Affairs Manager
Regulatory Affairs Leader
Senior Manager, Regulatory Affairs
Rochester Institute of Technology
State University of New York College at Cortland
Recommendations: 0
s****[email protected]
Cathy Walker
Administrative Assistant
Greater Boston Area
Administrative Assistant
Regulatory Affairs Specialist
Manager, Regulatory Affairs
Sr. Manager, Regulatory Affairs
Principal Associate, Regulatory Affairs
Director Regulatory Affairs
Senior Associate, Regulatory Affairs
Associate II, Regulatory Affairs
Associate Director Regulatory Affairs
Senior Director Regulatory Affairs
Massachusetts College of Pharmacy and Health Sciences
Boston College
DePauw University
Recommendations: 0
Regulatory Submissions
Drug Development
Regulatory Affairs
FDA
Pharmaceutical Industry
Clinical Development
eCTD
Biotechnology
c****[email protected]
c****[email protected]
Mary Alice Alexander
Senior Labeling Specialist
Greater Boston Area
Senior Labeling Specialist
Director, Global Labeling and Regulatory Operations
Director, Regulatory Operations
Documentation Manager, Regulatory Affairs
Manager, Regulatory Affairs Documentation
Technical Editor
President
Smith College
Recommendations: 0
Regulatory Submissions
Regulatory Affairs
Editing
Regulatory Documentation
Content Management
Regulatory Operations
Technical Editing
Copy Editing
m****[email protected]
Jenn Poole
Senior Manager, Regulatory Affairs
Greater Boston Area
Senior Manager, Regulatory Affairs
Co-owner, Corporate Treasurer
Clinical Operations Safety Manager
Senior Associate II, Reporting and Submission Compliance, Safety and Benefit Risk Management
Senior Quality Associate, Drug Safety and Risk Management
Senior Associate II, Clinical Trial Applications Unit, Regulatory Affairs
Senior Manager, Global Regulatory Affairs Neuroscience
Quality Assurance Documentation Specialist
Associate Director, Global Regulatory Intelligence and Policy
Senior Associate, Clinical Trial Compliance, Drug Safety and Risk Management
Manager, Regulatory Affairs
Associate Director, Global Regulatory Affairs Gastroenterology
Harvard University
Recommendations: 0
Regulatory Affairs
Clinical Trials
Patient Safety
Regulatory Requirements
CRO Oversight
Biotechnology
Risk Management
Drug Safety
j****[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]
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]
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]
Neil RAC
Manager, Regulatory Affairs
Greater Boston Area
Manager, Regulatory Affairs
Senior Regulatory Affairs Specialist
Senior Regulatory Affairs Specialist
Senior Regulatory Affairs Specialist
Regulatory Affairs Specialist II
Assumption College
Johnson & Wales University
Western New England University
Recommendations: 0
n****[email protected]
Nancy MacDonald
Manager, Regulatory Affairs
Greater Boston Area
Manager, Regulatory Affairs
Contract Reimbursement Consultant
Sr. Regulatory Engineer
Mgr. Regulatory & Clinical Affairs
Product Labeling Consultant
Manager Regulatory Affairs
Northeastern University - Graduate School of Business Administration
Slippery Rock University of Pennsylvania
Recommendations: 0
Regulatory Affairs
FDA
Product Launch
Medical Devices
Health Economics
Project Management
Management
Regulatory Submissions
n****[email protected]
n****[email protected]
Kate RPh
Pharmacy Technician
Greater Boston Area
Pharmacy Technician
Adjunct Faculty
Medication Reconciliation Intern
Senior Manager, Regulatory Advertising and Promotion Policy
Manager, Regulatory Affairs - Advertising and Promotion
Pharmacy Intern
Post-Doctoral Fellow, Regulatory Sciences - Advertising and Promotion
Senior Manager, Regulatory Affairs - Advertising and Promotion
Purdue University
Recommendations: 0
k****[email protected]
Jeanne O'Toole
Manager, Regulatory Affairs
Greater Boston Area
Manager, Regulatory Affairs
Sr. RA Specialist
Manager, Quality Assurance
Specialist, Quality Assurance
QA Associate
Clark University
Massachusetts College of Pharmacy and Health Sciences
Recommendations: 0
Regulatory Affairs
Design Control
Biotechnology
Biopharmaceuticals
Medical Devices
Sop
FDA
Change Control
j****[email protected]
Jill Ochoa
Senior Manufacturing Manager
Greater Boston Area
Senior Manufacturing Manager
Quality Manager, Consent Decree
Sales and Marketing Material Compliance Manager, Regulatory Affairs
Project Manager, Operational Excellence
Quality Assurance Specialist, Commercial and Clinical
Cell Culture Associate III
Product Release Specialist, Quality Assurance
Purification Manufacturing Associate III
California Lutheran University
California Lutheran University
Recommendations: 0
GMP
FDA
Sop
Validation
Change Control
LIMS
Documentum
Spreadsheets
j****[email protected]
Sue Hamann%2C RAC
President
Greater Boston Area
President
Chair Boston Chapter
Senior Manager, Regulatory Affairs
Regulatory Affairs Manager
Regulatory Affairs Manager
Director of Quality
Regulatory Affairs Leader
Chair, Program Chair
Sr. Quality Engineer
Sr. Regulatory Engineer
Quality Manager (Acting Director QA/RA))
Sr. Validation Engineer
Sr. V&V Engineer
Quality Engineer
Rochester Institute of Technology
State University of New York College at Cortland
Recommendations: 0
s****[email protected]
Petra Smit
Medical/Technical Writer
Greater Boston Area
Medical/Technical Writer
Principal
Manager, Regulatory and Clinical Affairs
Regulatory Affairs Manager
Senior Project Manager, Regulatory Affairs
Regulatory Affairs Project Manager
R&D Engineer
University of Twente
University of Twente
Recommendations: 0
FDA
Regulatory Affairs
Medical Devices
Regulatory Submissions
Quality System
Design Control
Clinical Development
Clinical Trials
p****[email protected]
Elizabeth Hook
Senior Regulatory Affairs Specialist
Greater Boston Area
Senior Regulatory Affairs Specialist
Director of Regulatory Affairs
Senior Regulatory Affairs Associate
Regulatory Affairs Specialist
Regulatory Affairs Associate
Regulatory Affairs Assistant
Regulatory Affairs Associate
Sr. Specialist, Regulatory Affairs
Associate Director Regulatory Affairs
Sr. Manager, Regulatory Affairs
Regulatory Consultant
Carnegie Mellon University
Recommendations: 0
Regulatory Affairs
Clinical Trials
Biotechnology
FDA
CRO
GCP
eCTD
Philip Alvarez
Medical Writing Consultant
Greater Boston Area
Medical Writing Consultant
Senior Drug Information Manager
Contract Medical Writer
Senior Medical Writer
Principal Medical Writer
Contract Science/Medical Writer
Associate Director, Medical Writing
Manager, Regulatory Affairs
Senior Clinical Research Manager
Senior Medical Writer
NYU School of Medicine, Sackler Insitute
Rutgers College of Pharmacy
Recommendations: 0
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
Augustina Gyimah
Global Regulatory Affairs Strategy Intern
Greater Boston Area
Global Regulatory Affairs Strategy Intern
Manager, Regulatory Strategy
Associate, Regulatory Strategy
Certified Pharmacy Technician
Certified Pharmacy Technician
Sr. Manager, Regulatory Affairs
Anatomy & Physiology II Lab Assistant
Microbiology Lab Assistant
Global Regulatory Affairs Strategy Associate
Orientation & Communication Management Graduate Assistant
Regis College
Regis College
Recommendations: 0
FDA
Pharmaceutical Industry
Oncology
Regulatory Affairs
Clinical Trials
Clinical Research
Microsoft Office
EMA
Elisabeth Garrison
Regulatory Affairs trainee
Greater Boston Area
Regulatory Affairs trainee
Associate Director, Clinical Regulatory
Senior Regulatory Scientist
Pharmacy intern
Senior Regulatory Scientist
Senior Manager, Regulatory Affairs
Regulatory Assessment trainee
Medical Writing trainee
Regulatory Scientist
Université Paris Sud (Paris XI)
Recommendations: 0
