Anthony Civitano

Experience

1. Labeling Associate

   Novartis

   Sep 2014 — Present

   Compile labeling section of NDA Annual Reports information for US marketed products• Prepare and submit Novartis labeler code registration, establishment registrations, and product drug listing to FDA electronically in compliance with SPL• Provide files for labeling registration in other countries• Responsible for hard-copy files for group• Work closely with US LD associates to coordinate labeling activities• Respond to labeling requests from other departments (Legal, Marketing, Finance, etc.)• Act as a liaison with Corporate Intellectual Properties to confirm continued use of trade-marks for our products• Maintain history of labeling activities (binders for discontinuation of product or SKU’s and trademarks)• Assist US LD associates with retrieving information from tools/application (e.g. AQWA ART, SAP)• Receive and distribute labeling as needed.• Provide support to the Regulatory QC manager and SPL Project manager as needed

Education

• Mount Saint Mary College

  Bachelor of Arts (B.A.), Information Technology

  2008 — 2010

• Rockland Community College

  Associate's degree, PC repair and support

  2000 — 2003

• Rockland Community College

  Associate's degree, Computer Systems Networking and Telecommunications

  2000 — 2003

Skills

• Pharmaceutical Industry
• Sop
• Fda
• Capa
• Quality System
• Gxp
• Change Control
• 21 Cfr Part 11
• Validation
• Quality Assurance
• Technology Transfer
• Cross-Functional Team Leadership
• Quality Control
• Gmp