Deborah Campagna

Director of Regulatory Operations at CG Oncology

Deborah Campagna has extensive work experience in regulatory operations and document control within the pharmaceutical industry. Deborah is currently the Director of Regulatory Operations at CG Oncology, a position they have held since 2020. Prior to this, they worked at Sillajen Biotherapeutics as the Associate Director of Regulatory Operations from 2011 to 2019. Their responsibilities at Sillajen included preparing and sending regulatory submissions to various agencies, managing submission timelines, and overseeing the preparation of IND updates, Annual Reports, and other documentation.

Before joining Sillajen, Deborah held the position of Senior Manager - Regulatory Operations at Anthera Pharmaceuticals from 2006 to 2011. Their role included preparing and sending regulatory submissions to the FDA and Health Canada, as well as establishing filing systems for organizing and archiving regulatory documents.

From 2005 to 2006, Deborah worked at Rinat Neuroscience as the Document Control Manager. In this role, they prepared and sent regulatory submissions to the FDA, maintained filing systems, and prepared submission-ready clinical documents.

Prior to Rinat Neuroscience, Deborah was a Technical Publishing Specialist II at VaxGen from 2002 to 2005. Deborah prepared and sent regulatory submissions to the FDA and provided administrative support to the Medical Affairs and Quality Assurance teams.

Deborah also worked as a Document Specialist at Tularik from 2001 to 2002. Their responsibilities included preparing and sending regulatory submissions, establishing and maintaining filing systems, and serving as the System Administrator for an Electronic Document Management System (EDMS). Deborah also generated and implemented Standard Operating Procedures (SOPs) for the use of the EDMS system.

Earlier in their career, Deborah worked at Coulter Pharmaceuticals as a CRA Assistant/Doc Processor from 1997 to 2000. Their role involved maintaining the Clinical Trial Master File, tracking the receipt of clinical study documents, processing clinical drug requests, and monitoring patient enrollment in clinical studies.

Deborah's work experience also includes a role as a Document Processor at Gilead Sciences from 1992 to 1997. In this position, they organized, compiled, and sent regulatory submissions to the FDA and prepared submission-ready clinical documents.

Deborah began their career in the pharmaceutical industry as an Administrative Assistant at Scios Nova (formerly Cal Bio) from 1988 to 1992. Their responsibilities included providing administrative support to various departments, drafting and formatting documents, and arranging travel.

Throughout their career, Deborah Campagna has gained comprehensive experience in regulatory operations, document control, and administrative support within the pharmaceutical industry.

Deborah Campagna pursued their education in a chronological manner. In 1981, they attended Abraham Lincoln High School from which they graduated in 1985 with a high school degree. After a substantial gap in their education, they enrolled at Arizona State University in 2013. There, they studied English Language and Literature, ultimately earning their Bachelor's Degree in that field in 2016.

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Timeline

  • Director of Regulatory Operations

    April, 2020 - present

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