2021 -2024 Senior Director Regulatory Affairs at Oxular, Inc. @
2019 -2021 Senior Director Regulatory Affairs @
2015 -2019 Director, Clinical and Regulatory Affairs at ProMedDx, LLC (a division of Precision for Medicine) @
2011 -2015 Clinical and Regulatory Project Manager @
2007 -2011 Director of cGMP Manufacturing-Gene Therapy Program @
2005 -2011 Quality Assurance Officer-Cancer Immunotherapy Program @
2003 -2011 Regulatory and Clinical Trials Project Manager @
2003 -2011 Clinical Development and Product Supervisor @
2003 -2011 Senior Research Associate @
2001 -2003 Research Associate @
1992 -2001 Senior Research Assistant @
1989 -1992 Research Assistant-IV @
1987 -1989 Research Assistant-III @
Pamela Education
San Diego State University
Advanced Certification (Regulatory Affairs)
2007-2007
University of Massachusetts Dartmouth
Bachelor of Science (BS) (Biology, General)
1982-1986
Pamela Skills
EMEA
ICH guidelines
R&D
ISO 13485
Drug Discovery
Biopharmaceuticals
Medical Devices
Clinical Research
Clinical Study Design
Clinical Trials
IND
510k
Human Factors Analysis
Usability Testing
Combination Products
FDA
Oncology Clinical Research
Tumor Immunology
Signal Transduction
Pharmacology
Toxicology
Animal Models
Monoclonal Antibodies
chimera
Growth Factors
Breast Cancer Research
Lung Cancer
lymphoma
melanoma
Quality System
Biochemistry
Regulatory Affairs
GMP
Cancer
CAPA
Clinical Development
In Vivo
Biotechnology
Regulatory Submissions
Oncology
SOP
Laboratory
Cell
Cell Biology
Laboratory Skills
Research and Development (R&D)
U.S. Food and Drug Administration (FDA)
Pamela Summary
Pamela, based in Cambridge, MA, US, is currently a Vice President of Regulatory Affairs at Thymmune Therapeutics. Pamela brings experience from previous roles at Oxular, Genocea, ProMedDx, LLC and Ximedica. Pamela holds a 2007 - 2007 Advanced Certification in Regulatory Affairs @ San Diego State University. With a robust skill set that includes EMEA, ICH guidelines, R&D, ISO 13485, Drug Discovery and more. Pamela has 2 emails and 1 mobile phone numbers on RocketReach.
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