Tess Franco

Experience

1. Associate Director, Regulatory Operations

   Xencor

   Feb 2016 — Present

   Format, publish, and submit documentation (new applications, amendments, annual reports, etc.) in eCTD format to Health Authorities according to FDA/ICH Guidelines; involves preparation of documents by scanning, rendering, bookmarking and hyperlinking • Collaborate with vendors who support regulatory submission document-related tasks • Maintain company archives of regulatory submissions (global eCTD submissions, including original filings and amendments) and communications with Health Authorities • Act as principal contact and archivist for eTMF documents • Provide training and hands-on assistance to personnel on eCTD templates • Coordinate with departments on the content, review, and assembly of regulatory documentation and associated timelines • Assist personnel with document level requirements and best practice techniques for compliant authoring • Ensure effective timeline management and communication relative to submission components • Stay current with electronic submission and regulatory documentation practices issued by global Health Authorities • Veeva Submissions, QualityDocs, and eTMF vaults