Thomas J. Noto

About Thomas J. Noto

20-year experienced leader with proven track-record in Pharmaceutical, Diagnostic and Medical Device Regulatory Affairs, Electronic Publishing and Document Management• Strong track record of successful regulatory interactions and filings, resulting in the approval of over 25 new drugs, devices and diagnostics.• Attracted and mentored talent, developed services and led global teams resulting in the consistent delivery of high-quality output aligned with business needs.• Very high organizational and technical aptitude, including regulatory process and workflow excellence, eCTD publishing, document management, quality systems and computer systems validation

Experience

1. Senior Director Regulatory Operations

   Lexicon Pharmaceuticals, Inc.

   Jun 2014 — Present · Princeton, NJ, US

   Manage and oversee development of regulatory operational strategies and implementation of technical systems for Regulatory Operations aspects of premarket and postmarket products, filing of applications and interactions with health authorities pertaining to Regulatory Operations issues or inquiries. • Oversee and maintain existing IND/CTA submissions on assigned programs. This involves the preparation of all amendments and annual reports in compliance with FDA regulations. • Work with CROs for ex-US submissions; coordinating with functional leads in various disciplines to assemble documents including writing, reviewing, editing and approval of submissions in a team-oriented environment. • Oversee the Electronic Documentation System used for assembling and archiving submissions at Lexicon and leads the Regulatory Publishing function. • Assist with pre-IND meeting briefing packages and initial IND submissions for new programs; representing the department on multi-disciplinary development teams; • Mentor personnel

Education

• Gettysburg College

  BA, English Literature

  1988 — 1992

Skills

• Clinical Research
• Ind
• Strategy
• Drug Development
• Biotechnology
• Clinical Development
• Quality System
• Ich-Gcp
• Document Management
• Pharmaceutics
• CRO
• Documentum
• Quality Assurance
• Clinical Trials
• Edc
• Ctms
• Pharmaceutical Industry
• Sop
• Fda
• Business Process Reengineering
• Ectd
• Regulatory Submissions
• Regulatory Affairs