Remote Regulatory Submissions Manager

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

Benefits offered by this job

401(k) match

Tuition reimbursement

Comprehensive benefits

Job summary

Otsuka America Pharmaceutical Inc. in the United States is seeking a Manager Regulatory Operations to coordinate timely regulatory publishing deliverables aligned with program strategy.

You will lead or support GRA efforts, liaise with affiliates, ensure submissions meet health authority requirements, and drive process improvements across eCTD, publishing, and archival activities. This role emphasizes collaboration with R&D, regulatory affairs, and external partners.

Qualifications

• Minimum 5 years of regulatory operations experience and in-depth experience with electronic submissions.
• Knowledge of FDA/EMA/HC/Swiss Medic regulations for electronic and paper submissions.
• Expert knowledge of eCTD sequencing and lifecycle management.
• Experience with Documentum and publishing tools.

Responsibilities

• Coordinate regulatory publishing deliverables and oversee submissions.
• Ensure submissions are completed on time, within budgets, and with high quality.
• Liaise with affiliates for coordinating and publishing content.
• Own delivery of electronic regulatory submissions and maintain timelines.
• Design processes to maximize electronic lifecycle submissions and continuous improvement.
• Oversee staff and vendor work for submissions and quality control.

Skills

Regulatory ops

Regulatory publishing

GxP compliance

Cross-functional

Project leadership

Documentation management

Tools

Documentum

DocuBridge

InSight Publisher

GlobalSubmit Validate

GlobalSubmit Review

ISIToolbox

Microsoft Office

SharePoint

Job description

Otsuka America Pharmaceutical Inc. in the United States is seeking a Manager Regulatory Operations to coordinate timely regulatory publishing deliverables aligned with program strategy.

You will lead or support GRA efforts, liaise with affiliates, ensure submissions meet health authority requirements, and drive process improvements across eCTD, publishing, and archival activities. This role emphasizes collaboration with R&D, regulatory affairs, and external partners.