Remote Regulatory Submissions & Publishing Manager

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

Job summary

Otsuka America Pharmaceutical Inc. in the United States is seeking a Manager Regulatory Operations to coordinate high-quality regulatory publishing deliverables for assigned programs, ensure on-time submissions, and drive process improvements in line with agency guidance.

You will lead and support GRA efforts, liaise with affiliates, manage electronic submissions (eCTD), and mentor staff and vendors to maintain compliance and timely delivery across regulatory functions.

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 (e.g., DocuBridge, InSight Publisher, GlobalSubmit Validate, GlobalSubmit Review, and ISIToolbox).
• Strong computer skills with demonstrated experience and ability in Microsoft Office suite (Word, Excel, Access, and 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, monitoring, and oversight.
• Ensure assigned submissions are made with quality, on-time, and within budgets.
• Acts as primary liaison while coordinating regulatory publishing activities for all R&D functions.
• Liaise with affiliates for coordinating and publishing defined content.
• Owns delivery of electronic regulatory submissions to ensure processes are followed and timelines met.
• Designs and implements processes and systems to maximize electronic lifecycle submissions.
• Ensures submission and archival activities.
• Provides direction to staff and contingent workers to assure quality control checks.

Skills

Regulatory submissions

FDA/EMA/HC/Swiss Medic regulations

eCTD lifecycle

Document management systems

Project management

NDAs/MAAs experience

Regulatory publishing

MS Office & SharePoint

Cross-functional collaboration

Tools

DocuBridge

InSight Publisher

GlobalSubmit Validate

GlobalSubmit Review

ISIToolbox

Documentum

SharePoint

Job description

Otsuka America Pharmaceutical Inc. in the United States is seeking a Manager Regulatory Operations to coordinate high-quality regulatory publishing deliverables for assigned programs, ensure on-time submissions, and drive process improvements in line with agency guidance.

You will lead and support GRA efforts, liaise with affiliates, manage electronic submissions (eCTD), and mentor staff and vendors to maintain compliance and timely delivery across regulatory functions.