Remote Regulatory Submissions Lead

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

Job summary

Otsuka America Pharmaceutical Inc. seeks a Manager Regulatory Operations to coordinate high-quality regulatory publishing deliverables for assigned programs, ensuring on-time submissions and alignment with agency guidance.

You will lead regulatory publishing activities, oversee staff and vendor partners, and drive continuous process improvements while maintaining archiving and lifecycle management in accordance with regulatory standards.

Qualifications

• Minimum 5 years of regulatory operations experience and direct experience with electronic submissions.
• Knowledge of FDA/EMA/HC/Swiss Medic regs and guidance for electronic and paper submissions.
• Expert in regulatory operations including formatting, publishing, submitting, lifecycling, and archiving (eCTD).
• Demonstrated ability to manage time-intensive deliverables.
• Knowledge of Documentum and publishing tools listed in qualifications.

Responsibilities

• Coordinate regulatory publishing and submission assignments, monitoring, and oversight.
• Ensure submissions are high quality, on-time, and within budget.
• Liaise with affiliates for coordinating and publishing defined content.
• Deliver electronic regulatory submissions in line with health authority requirements.

Skills

Regulatory operations

Electronic submissions

FDA/EMA knowledge

Document management systems

Office suite & SharePoint

NDAs/MAAs

Project management

Vendor management

Tools

Documentum

DocuBridge

InSight Publisher

GlobalSubmit Validate

GlobalSubmit Review

ISIToolbox

Job description

Otsuka America Pharmaceutical Inc. seeks a Manager Regulatory Operations to coordinate high-quality regulatory publishing deliverables for assigned programs, ensuring on-time submissions and alignment with agency guidance.

You will lead regulatory publishing activities, oversee staff and vendor partners, and drive continuous process improvements while maintaining archiving and lifecycle management in accordance with regulatory standards.