Todd Philipps
1940 West Ontario Ave. · Corona, CA 92882
(951) 545-3501 · Email:
Summary of Work Experience:
Subject Matter Expert in evaluation and implementation of eCTD software and business processes. Balanced with technical skills to work well with both Regulatory and IT staff.
Work Experience:
Regulatory Affairs, Associate III, Anchen Pharmaceuticals, Inc. 2010 – current
· Lead implementation of MedXview eCTD software. Transitioned from paper submission environment to fully GxP validated eCTD environment within 6 months of project start.
· Developed Regulatory Operations role. Established eSubmission processes, archival processes and regulatory information management, eSubmission and SPL SME roles.
· Digitized complete paper library providing Anchen employees and off-site partners access to all submission documents from their desktop. Converted 415 paper volumes to 18 gigabyte of online data.
· Structured Product Labeling (SPL) subject matter expert including SPL for draft labeling submissions, drug listings, content of labeling and establishment registration.
· Implemented TVT tool suite to aid document reviews and comparisons. Saving an average of 8 hours review time per comparison with an average of 4 comparisons per labeling submission. Also providing 99.9% accuracy.
· Developed submission and product tracking database providing central repository for all regulatory product related and submission related information.
· Developed materials usage database to aid regulatory associates in tracking raw materials used in production of final products as well as tracking authorized labs to test raw materials and final products.
Regulatory Consultant, Image Solutions Inc. 2009 – 2010
· Develop Best Practice, Insider Tips & How-to documents for use on ISI’s support portal ISIOnCall
· Provide business process and best practice recommendations regarding eCTD/CTD dossiers to ISI clients
· Provide clients with Regulatory guidance interpretations, flexibilities, and requirements
· Write custom work instruction documents on a client-by-client basis to include business process, software processes and regulatory information
· Conduct Business process workshops to enable customers to develop/refine business processes as they relate to Electronic Submissions
· Provide software specific training to customers for ISI such as: Introduction to eCTD, ISIWriter, eCTDXPress, ISIPublisher, Technical Administration
· Provide guidance and implementation to clients when transitioning from paper submissions to electronic
· Software implementation project management responsibilities for ISI clients
· Provide staff augmentation for various Regulatory and IT positions
Regulatory Affairs Operations, Associate III, Watson Labs 2007 – 2009
· Key Business lead for Corporate-wide Electronic Submission (eCTD) software implementation. Cost savings of over $560,000/year for Corona Site.
· Defined user requirements, user acceptance testing procedures and SOPs for eCTD and Electronic Submission Gateway (ESG) systems.
· Developed and conducted software training covering all aspects of new software systems. Personally trained approximately 75 people.
· Defined and published Business Practice guidelines covering both Pre-Approval submissions and Post-Approval Submissions
· Subject Matter Expert supporting 4 corporate sites across the US.
· Managing integration of off-shore eCTD submissions into corporate systems.
· Work with a team of 3 to compile and publish 30 ANDAs and approximately 200 amendment/supplements per year, Corona Site.
Configuration / Engineering Manager, Relsys International, Inc. 2002 – 2007
· Manage Quality Assurance server / environment administration and product delivery functions providing stable and reusable environments for testing.
· Manage 10 servers including Web and Database servers for product validation and issue verification activities.
· Restructured final product delivery methods, saving 60% of labor time previously spent.
· Extensive experience in SDLC including gather customer requirements, investigating customer business scenarios, writing requirements, actual development, QA activities and onsite customer installations.
· Managed development efforts between USA and India Office, including offshore team of 8 engineers with local team of QA, Database and Marketing.
· Delivered initial Reporting Product in 7 months, after existing team labored 2 years with no success.
Engineering Team Leader, ConsumerInfo.com 1999 – 2002
· Teamed with marketing department to define requirements, design and scope of projects.
· Managed 12 team members on multiple tasks across multiple projects.
· Maintained and supported ecommerce websites and servers, averaging over 10 million unique visitors per month and 75,000 orders per week.
· Successfully integrated 3rd party tools into websites through collaborative efforts with vendors, credit card clearing and home sales data.
· Managed new development, maintenance, server administration and database administration.
· Converted all company sites from Perl & FoxPro to ASP & SQL Server 7.0.
Systems Analyst III/Web Developer, Iowa State University 1988 – 1999
· Developed and provided support for ISU’s AccessPlus, an interactive Student Information System available via web browser or campus Kiosks that averages 165,000 hits per month
· Webmaster for ISU dealing with problem resolutions, upgrades and client support.
· Developed, implemented and maintained batch programs in support of numerous CICS systems, using CA-Easytrieve and COBOL
· Conducted systems analysis, design and programming with MVS computer systems supporting ISU’s Human Resources Department
Skills:
Tools/Applications: CSC Total Regulatory Solution, ISIToolbox, ISIWriter, MedXview eCentral and eLabel, Global Submit Review/Publish and Validate, Text Verification Tool (TVT), i4i A4L (SPL), Sharepoint, LiveLink, Visual Studio, ASP.NET, SQL Server, Oracle
Languages: .Net, ASP, JavaScript, VBScript, HTML, DHTML, CSS, Java, VB 6.0, C#, Transact-SQL, XML, COM, DCOM, ActiveX, COBOL
Education: BA Computer Information Systems, University of Northern Iowa
Developing ASP.Net, Microsoft Training, 2003
Developing in C#, Microsoft Training, 2003
Business Objects Developer Training, 2003
NCCPT Personal Training Certification, 2003
Organizations:
Drug Information Association (DIA) since 2007
Orange County Regulatory Affairs (OCRA) since 2007
National Council for Certified Personal Trainers (NCCPT) 2005