Regulatory Submissions Lead — Remote

Otsuka America Pharmaceutical Inc.; San Juan (PR); Remote; USD 108,000 - 161,000; Full time

Benefits offered by this job

Medical, dental, vision benefits

401(k) match

Paid holidays

Paid time off

Job summary

Otsuka America Pharmaceutical Inc. seeks a Manager Regulatory Operations to coordinate regulatory publishing deliverables and support GRA efforts across programs. You will ensure on-time submissions, align with health authority requirements, and drive process improvements.

The role partners with R&D functions and affiliates to publish content, manage lifecycle submissions, and mentor staff. A minimum of five years in regulatory operations and strong knowledge of eCTD are required.

Qualifications

• Minimum 5 years in regulatory operations.
• Knowledge of FDA/EMA/HC/Swiss Medic guidelines for electronic and paper submissions.
• Experience with eCTD sequences (formatting, publishing, lifecycle, archiving).
• Experience managing time-intensive deliverables and coordinating with multiple stakeholders.
• Expert knowledge of document management systems and publishing tools.

Responsibilities

• Coordinate regulatory publishing assignments, monitoring, and oversight; lead or support GRA efforts.
• Ensure submissions are on-time, within budgets, and of high quality.
• Act as liaison coordinating regulatory publishing activities for all R&D functions.
• Liaise with affiliates for coordinating and publishing defined content.
• Own delivery of electronic regulatory submissions and ensure compliance with health authority requirements.
• Design and implement processes to maximize lifecycle submissions and continuous improvement.
• Provide direction to staff and contingent workers for quality control checks.
• Oversee project team members and vendor partners for assigned submissions.
• Lead process mapping teams and develop work instructions.

Skills

Regulatory publishing

GxP regulatory

Project leadership

Microsoft Office & SharePoint

Vendor coordination

Tools

Documentum

DocuBridge

InSight Publisher

GlobalSubmit

ISIToolbox

Job description

Otsuka America Pharmaceutical Inc. seeks a Manager Regulatory Operations to coordinate regulatory publishing deliverables and support GRA efforts across programs. You will ensure on-time submissions, align with health authority requirements, and drive process improvements.

The role partners with R&D functions and affiliates to publish content, manage lifecycle submissions, and mentor staff. A minimum of five years in regulatory operations and strong knowledge of eCTD are required.