Regulatory Submissions & Publishing Lead

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

Job summary

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

The role leads staff and vendor teams, drives electronic lifecycle enhancements, and collaborates with affiliates to publish content that meets regulatory standards. The successful candidate will oversee submission delivery, maintain regulatory files, and provide guidance on processes

Qualifications

• Minimum 5 years of regulatory operations experience with first-hand electronic submissions.
• Knowledge of FDA/EMA/HC/Swiss Medic regulations for electronic and paper submissions.
• Expert in eCTD sequences, publishing, lifecycle management and archiving.
• Demonstrated ability to manage time-intensive deliverables.
• Experience with Document Management Systems and publishing tools.
• Strong MS Office and SharePoint skills, plus cross-functional collaboration.
• Recent experience with NDAs/MAAs is essential.

Responsibilities

• Coordinate regulatory publishing and submission activities for R&D programs.
• Ensure submissions are high quality, on time, and within budget.
• Lead or support GRA efforts and liaise with affiliates for publication content.
• Oversee electronic submissions delivery and compliance with regulatory standards.
• Design processes to maximize electronic lifecycle maintenance and continuous improvements.
• Provide guidance to staff and contractors to ensure QC of submission documents.

Skills

Regulatory operations

eCTD submissions

Regulatory publishing

Project coordination

FDA/EMA knowledge

Tools

Documentum

DocuBridge

InSight Publisher

GlobalSubmit

ISIToolbox

SharePoint

Microsoft Office

Job description

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

The role leads staff and vendor teams, drives electronic lifecycle enhancements, and collaborates with affiliates to publish content that meets regulatory standards. The successful candidate will oversee submission delivery, maintain regulatory files, and provide guidance on processes