Dexter Reyes
About Dexter Reyes
Dexter Reyes is a Senior Manager at Mirati Therapeutics, with extensive experience in document quality operations and compliance auditing in the pharmaceutical industry. He has a strong background in reviewing regulatory documents and conducting clinical site audits, having worked at Arena Pharmaceuticals for nearly a decade.
Current Role at Mirati Therapeutics
Dexter Reyes currently serves as a Senior Manager at Mirati Therapeutics, a position he has held since 2021. His role is based in San Diego, California. In this capacity, he is responsible for overseeing various operational aspects related to regulatory compliance and quality assurance within the organization.
Previous Experience at Arena Pharmaceuticals
Prior to joining Mirati Therapeutics, Dexter Reyes worked at Arena Pharmaceuticals, Inc. for a total of nine years in various roles. He began as an EH&S Technician and progressed to Senior Specialist and Alternate Radiation Officer. He later served as a Compliance Auditor and then as Senior Manager of Document Quality Operations. His tenure at Arena spanned from 2003 to 2021.
Expertise in Regulatory Submissions
Dexter Reyes is well-versed in reviewing Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) documents. His expertise supports Investigational New Drug (IND), New Drug Application (NDA), and other regulatory submissions across various regions of the world. He plays a critical role in ensuring that documentation meets regulatory standards.
Leadership in Clinical Site Audits
As the primary lead auditor for clinical site audits for Phase I to II studies, Dexter Reyes coordinates global audits. He proactively identifies potential compliance issues at clinical sites and manages follow-up corrective actions. His leadership ensures adherence to study protocols and regulatory requirements.
Guidance on GCP/GLP Regulations
Dexter Reyes provides guidance on the interpretation and application of GCP and GLP regulations. His knowledge supports teams in understanding compliance requirements, thereby enhancing the quality and integrity of clinical research activities.