Remote Regulatory Submissions Manager

Otsuka America Pharmaceutical Inc.; Olympia (WA); Remote; USD 108,000 - 161,000; Full time

Job summary

Otsuka America Pharmaceutical Inc. is seeking a Manager of Regulatory Operations to coordinate high-quality regulatory publishing deliverables for assigned programs.

You will lead or support GRA efforts, ensure on-time submissions, and drive process improvements in the electronic submission lifecycle. You will liaise with affiliates, manage vendors, and provide direction to staff to ensure compliance with FDA/EMA/HC guidelines and electronic regulatory standards.

Qualifications

• Minimum of 5 years of regulatory operations experience and first-hand experience with electronic submissions
• Knowledge of FDA/EMA/HC/Swiss Medic regulations for electronic and paper submissions
• Excellent knowledge of regulatory operations including formatting, publishing, submitting, lifecycling, and archiving (eCTD) sequences
• Experience managing and producing time-intensive deliverables
• Expert knowledge of Document Management Systems and publishing tools
• Strong MS Office and SharePoint skills
• Knowledge of NDAs / MAAs is essential

Responsibilities

• Coordinate regulatory publishing deliverables and submissions
• Ensure submissions are on-time, within budget and of high quality
• Liaise with R&D affiliates for publishing activities
• Own electronic submission delivery and compliance with regulatory standards
• Design processes for lifecycle submissions and continuous improvements
• Oversee staff and vendor partners on submissions
• Provide direction for regulatory staff and mapping teams
• Maintain regulatory work instructions and organization of files
• Provide publishing guidance to other departments

Skills

Regulatory operations

Electronic submissions

eCTD publishing

Document management systems

MS Office & SharePoint

NDAs & MAAs

Vendor management

Process improvement

Regulatory liaison

Tools

DocuBridge

InSight Publisher

GlobalSubmit Validate

GlobalSubmit Review

ISIToolbox

Documentum

SharePoint

Job description

Otsuka America Pharmaceutical Inc. is seeking a Manager of Regulatory Operations to coordinate high-quality regulatory publishing deliverables for assigned programs.

You will lead or support GRA efforts, ensure on-time submissions, and drive process improvements in the electronic submission lifecycle. You will liaise with affiliates, manage vendors, and provide direction to staff to ensure compliance with FDA/EMA/HC guidelines and electronic regulatory standards.