Senior Director Regulatory Affairs at Oxular, Inc. @ (October 2021 - October 2024)
Senior Director Regulatory Affairs @ (August 2019 - October 2021)
Director, Clinical and Regulatory Affairs at ProMedDx, LLC (a division of Precision for Medicine) @ (July 2015 - August 2019)
Clinical and Regulatory Project Manager @ (March 2011 - July 2015)
Director of cGMP Manufacturing-Gene Therapy Program @ (January 2007 - March 2011)
Quality Assurance Officer-Cancer Immunotherapy Program @ (January 2005 - March 2011)
Regulatory and Clinical Trials Project Manager @ (January 2003 - March 2011)
Clinical Development and Product Supervisor @ (January 2003 - March 2011)
Senior Research Associate @ (January 2003 - March 2011)
Research Associate @ (January 2001 - January 2003)
Senior Research Assistant @ (January 1992 - January 2001)
Research Assistant-IV @ (October 1989 - January 1992)
Research Assistant-III @ (October 1987 - November 1989)
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, Regulatory Affairs - Thymmune at United Therapeutics Corporation. Pamela brings experience from previous roles at Thymmune Therapeutics, Oxular, Genocea and ProMedDx, LLC. 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 1 emails and 2 mobile phone numbers on RocketReach.
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