Regulatory Operations Lead — eCTD Submissions & Strategy

Otsuka Pharmaceutical Co., Ltd; United States; Remote; USD 108,000 - 161,000; Full time

Job summary

Otsuka seeks a Manager of Regulatory Operations to coordinate high-quality, on-time regulatory publishing deliverables for assigned programs. You will lead electronic submissions, liaise with global affiliates, and drive process improvements to ensure compliance with health authority requirements.

The role requires 5+ years in regulatory operations, strong eCTD publishing skills, and experience with multiple regulatory bodies. Collaboration across departments and vendors is essential for success.

Qualifications

• Minimum 5 years of regulatory operations experience with electronic submissions.
• Experience with FDA/EMA/HC/Swiss Medic guidelines for eCTD submissions.
• Expertise in publishing, archiving, lifecycling, and document management systems.

Responsibilities

• Coordinate regulatory publishing activities for R&D submissions.
• Lead or support GRA efforts and ensure on-time, compliant submissions.
• Provide guidance for process mapping and staff direction.
• Oversee vendor partners and maintain regulatory files.

Skills

Regulatory operations

eCTD publishing

Regulatory submissions

Project management

Leadership

Education

RAPS Certification (preferred)

Tools

Documentum

DocuBridge

InSight Publisher

GlobalSubmit Validate

GlobalSubmit Review

ISIToolbox

SharePoint

MS Office

Job description

Otsuka seeks a Manager of Regulatory Operations to coordinate high-quality, on-time regulatory publishing deliverables for assigned programs. You will lead electronic submissions, liaise with global affiliates, and drive process improvements to ensure compliance with health authority requirements.

The role requires 5+ years in regulatory operations, strong eCTD publishing skills, and experience with multiple regulatory bodies. Collaboration across departments and vendors is essential for success.