Regulatory Submissions Lead — Global eCTD & Publishing

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

Benefits offered by this job

Comprehensive medical coverage

Dental and vision benefits

401(k) with match

Tuition reimbursement

Paid holidays and leave

Job summary

Otsuka Pharmaceutical Co., Ltd. is seeking a Manager Regulatory Operations to coordinate high-quality regulatory publishing deliverables aligned with program strategy.

The role monitors agency guidance updates, drives process improvements, and oversees electronic submissions to ensure timelines and quality meet health authority standards. The position requires extensive experience in regulatory operations, publishing tools, and document management systems, with strong leadership and

Qualifications

• Minimum of 5 years of regulatory operations experience and in-depth first-hand experience with application electronic submissions.
• Knowledge of FDA/EMA/HC/Swiss Medic regulations and guidance for electronic and paper submissions.
• Excellent knowledge and experience in regulatory operations, including formatting, publishing, submitting, lifecycling, and archiving (eCTD) sequences.
• Demonstrated performance in managing and producing time-intensive deliverables.
• Expert knowledge of Document Management Systems (Documentum preferred) and publishing tools (DocuBridge, InSight Publisher, GlobalSubmit Suite, ISIToolbox).
• Strong computer skills with Microsoft Office suite (Word, Excel, Access, PowerPoint) and SharePoint.
• Knowledge in developing processes across multiple departments/divisions that leverage technology.
• Recent experience with NDAs / MAAs is essential.

Responsibilities

• Coordinate regulatory publishing and submission assignments with oversight for quality and timeliness.
• Serve as liaison coordinating regulatory publishing activities for R&D functions.
• Own delivery of electronic regulatory submissions to ensure compliance with health authority requirements.
• Design and implement processes to maximize electronic lifecycle maintenance submissions.
• Provide direction to staff and contingent workers for quality checks of submission documents.
• Oversee project team members and vendors for assigned submissions.
• Lead Process Mapping Teams for Regulatory Submissions and Annual Reports.
• Maintain regulatory operations work instructions and build cross-functional relationships.

Skills

Regulatory publishing

eCTD submissions

Regulatory operations

Document management

Project leadership

NDAs/MAAs knowledge

Cross-functional collaboration

Process improvement

Tools

Documentum

DocuBridge

InSight Publisher

GlobalSubmit Suite

ISIToolbox

SharePoint

Microsoft Office

Job description

Otsuka Pharmaceutical Co., Ltd. is seeking a Manager Regulatory Operations to coordinate high-quality regulatory publishing deliverables aligned with program strategy.

The role monitors agency guidance updates, drives process improvements, and oversees electronic submissions to ensure timelines and quality meet health authority standards. The position requires extensive experience in regulatory operations, publishing tools, and document management systems, with strong leadership and