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 INDs/CTAs/NDAs/MAAs, Safety & PANI, Submissions• 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• Manage & Contribute to tracking and archiving of regulatory communications and submissions• Manage and perform all functional aspects of Word formatting, PDF publishing and eCTD backbone compilation for regulatory submissions• Participate in evaluation, selection, validation (UAT) and implementation of software or systems related to submission planning, preparation, assembly, dispatch, and/or archiving• Maintain expert knowledge of electronic submission and computerized system validation standards• Contribute to and develop internal work instructions and SOPs as needed• Participate in workstreams for process improvements in document management and regulatory information tracking• Participate in collaborative relationships with site personnel, colleagues and vendors

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 entries, invoicing, etc.)• 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• Ensures that the project team understand and work to the scope of the contract• Identifies new opportunities through Change In Scope or add-on business from existing workProvide basic paper and electronic publishing services including document preparation, legacy conversion, scanning, rendering, bookmarking, hyperlinking, compilation, table of contents creation, volumization, pagination, and formatting of reports and simple submissions.• Perform basic document management tasks including file transfer, storage, tracking, and archival.• Maintain familiarity with current global regulatory submission standards in addition to departmental standard operating procedures and work instructions.• Responsible for the preparation of submission documents and submission dispatch• Participation in the HA review process.• Compiles CMC-Sections, DMF, Active Pharmaceutical Ingredients, Pharmaceutical Formulation Intermediates for Finished Dosages, Pharmaceutical Formulation in CTD format to USFDA.• Respond to deficiencies/queries received from Regulatory Authorities and customers.• Co-ordinate and provide support for preparation and dispatch of quality regulatory documents/dossiers CTD format in agreed timeframes. (E.g. Regulatory Responses, Annual update & Amendments).

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•Maintain awareness of regulatory formatting requirements•Actively participates in authoring support and submission management projects and initiatives

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

Bachelors Of Science, Pharmaceutical Sciences