Remote Regulatory Submissions Lead

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

Job summary

Otsuka America Pharmaceutical Inc. is seeking a Manager Regulatory Operations to coordinate high-quality, on-time regulatory publishing deliverables across assigned programs, ensuring compliance with agency guidance and internal schedules.

The role involves leading regulatory publishing activities, coordinating with R&D and affiliates, managing vendor work, and driving process improvements to maximize efficiency.

Qualifications

• Minimum of 5 years of regulatory operations experience with electronic submissions.
• Knowledge of FDA/EMA/HC/Swiss Medic regulations and guidance.
• Expert knowledge of eCTD formatting, publishing, lifecycle management, and archiving.
• Experience with Document Management Systems and publishing tools.
• Strong MS Office and SharePoint skills.

Responsibilities

• Coordinate regulatory publishing assignments and submissions.
• Ensure timely, on-budget delivery of submissions.
• Liaise with affiliates for publishing content.
• Oversee electronic submission delivery to health authorities.
• Design processes to optimize electronic lifecycle submissions.
• Provide direction to staff and vendors to ensure quality control.
• Lead project teams and act as liaison for regulatory submissions.
• Develop and maintain work instructions.

Skills

Regulatory operations

FDA/EMA/HC knowledge

eCTD submissions

Project coordination

Staff guidance

Regulatory systems

Tools

DocuBridge

InSight Publisher

GlobalSubmit

ISIToolbox

SharePoint

MS Office

Job description

Otsuka America Pharmaceutical Inc. is seeking a Manager Regulatory Operations to coordinate high-quality, on-time regulatory publishing deliverables across assigned programs, ensuring compliance with agency guidance and internal schedules.

The role involves leading regulatory publishing activities, coordinating with R&D and affiliates, managing vendor work, and driving process improvements to maximize efficiency.