Remote Regulatory Submissions Manager

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

Job summary

Otsuka America Pharmaceutical Inc. is seeking a Manager of Regulatory Operations to coordinate high-quality regulatory publishing deliverables aligned with program strategies.

The role focuses on knowledge of agency guidance, process improvements, and on-time submissions across R&D functions. Responsibilities include overseeing electronic submissions, vendor coordination, and staff guidance to ensure compliance with regulatory standards.

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

• As an integral member of Otsuka’s regulatory operations team, provides regulatory publishing and submission assignments, monitoring, and oversight, as well as a lead or support for GRA efforts
• Ensures assigned submissions are made with quality, on-time, and within established 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, as well as quality and timelines are met in accordance with health authority requirements and Otsuka leadership established schedules
• Designs and implements processes and systems to maximize electronic lifecycle / maintenance submissions requirements, including a focus on continuous improvements
• Ensures submission and archival activities
• Provides direction to staff and contingent workers to assure quality control checks of documents intended for submission to regulatory agencies and compliance with electronic regulatory standards
• Oversees project team members for assigned submissions, including work assignments to vendor partners
• Provides leadership and guidance for Process Mapping Teams (e.g., Key stakeholder for Regulatory Submissions, Key stakeholder for Annual Reports)
• Develops and maintains assigned regulatory operations work instructions
• Establishes and builds collaborative relationships with colleagues
• Responsible for organizing and maintaining regulatory files
• Provides regulatory publishing guidance to other departments / functions

Skills

Regulatory publishing

Regulatory submissions

Project management

Documentation management

Microsoft Office

Tools

Documentum

DocuBridge

InSight Publisher

GlobalSubmit

ISIToolbox

SharePoint

Job description

Otsuka America Pharmaceutical Inc. is seeking a Manager of Regulatory Operations to coordinate high-quality regulatory publishing deliverables aligned with program strategies.

The role focuses on knowledge of agency guidance, process improvements, and on-time submissions across R&D functions. Responsibilities include overseeing electronic submissions, vendor coordination, and staff guidance to ensure compliance with regulatory standards.