Regulatory Publishing & Submissions Lead

Socket.dev; United States; Remote; USD 108,000 - 161,000; Full time

Benefits offered by this job

Medical benefits

401(k) match

Paid time off

Job summary

Otsuka America Pharmaceutical, Inc. is seeking a Manager of Regulatory Operations to coordinate high-quality, on-time regulatory publishing deliverables and oversee electronic submissions to regulators.

You will identify impacts of agency guidance and drive process improvements across R&D functions. The role requires extensive knowledge of eCTD submissions, document management, and collaboration with affiliates, vendors, and internal teams to ensure timely and compliant content across regulatory

Qualifications

• Minimum 5 years of regulatory operations experience and direct experience with electronic submissions

Responsibilities

• Provide regulatory publishing and submission assignments, monitoring, and oversight
• Ensure submissions are high quality, on time, and within budget
• Coordinate regulatory publishing activities for all R&D functions
• Liaise with affiliates for content coordination and publishing
• Own electronic submission delivery to meet health authority requirements and schedules
• Design and implement processes to maximize electronic lifecycle and maintenance submissions
• Oversee submission archival activities and quality control checks for submission documents
• Provide direction to staff and contingent workers for quality control checks on submission documents
• Lead project teams and assign work to vendors as needed
• Lead and guide process mapping teams for regulatory submissions and annual reports
• Develop and maintain regulatory operations work instructions
• Build collaborative relationships across teams
• Organize and maintain regulatory files
• Provide regulatory publishing guidance to other departments

Skills

Regulatory operations

Regulatory publishing

Project management

Communication

Leadership/Staff management

Problem solving

Process improvement

Documentation control

Tools

Documentum

DocuBridge

InSight Publisher

GlobalSubmit Suite

ISIToolbox

SharePoint

Microsoft Office

Job description

Otsuka America Pharmaceutical, Inc. is seeking a Manager of Regulatory Operations to coordinate high-quality, on-time regulatory publishing deliverables and oversee electronic submissions to regulators.

You will identify impacts of agency guidance and drive process improvements across R&D functions. The role requires extensive knowledge of eCTD submissions, document management, and collaboration with affiliates, vendors, and internal teams to ensure timely and compliant content across regulatory