Christopher Doan Email & Phone Number

Oxnard, CA, US

Thousand Oaks, CA, US

Thousand Oaks, CA, US

Thousand Oaks, CA, US

• Format Submission Components – from Source MS Word documents to submission-ready and style guide compliant submission components
• Publish regulatory submissions, including updating existing dossiers, converting to electronic (eCTD), and submission to global health authorities and managing all lifecycle submission. Including but not limited to.
• Coordinate technical aspects for submissions (e.g., eCTD document granularity, use of content templates, document formatting, eCTD application location and lifecycle assignment, and publishing QC)
• Contribute to efficient use and process for regulatory information tools and systems (e.g., eCTD publishing tools, regulatory information management system (RIM), and electronic templates)
• Communicate potential risks to submission plans and propose risk mitigation strategies
• Manage & Contribute to key performance and compliance indicators

Durham, North Carolina, US

• Responsible for project planning and set-up and routinely interacts with the assigned Project Specialist (PS) or Project Manager (PM) to appropriately control the project (e.g. project set-up, forecasting and financial.
• Functions as the main client contact and ensures accurate project reporting is in place
• Ensures that the project team delivers to meet the client expectations for quality and timeliness
• Ensures that appropriate risk identification and issue-escalation procedures are in place
• Ensures project specific training compliance of the project team
• Ensures and/or manages project financials including provision of accurate revenue forecasts

Tokyo, JP, JP

Retained Responsibilities from Baxalta

Illinois, US

Retained Responsibilities from Baxter

Deerfield, Illinois, US

• Provides support and technical assistance for formatting regulatory submissions verifying and applying appropriate formatting ensuring that documentation meets Baxter’s submission-ready standards
• Formats MS Word documents by applying appropriate styles and formatting techniques to text
• Formats PDF documents in Adobe Acrobat and ISIToolbox
• Formats regulatory submission documents using electronic document management system
• Responsible for quality of documentation formatted for electronic or paper-based submissions
• Assists with the update of authoring support processes and SOPs

Master Of Science, Regulatory Affairs For Drugs, Biologics, And Medical Devices

Bachelors Of Science, Pharmaceutical Sciences