Remote Regulatory Submissions Lead

Otsuka America Pharmaceutical Inc.; Carson City (NV); Remote; USD 108,000 - 161,000; Full time

Job summary

Otsuka America Pharmaceutical Inc. is seeking a Manager Regulatory Operations to coordinate high-quality regulatory publishing deliverables aligned with program strategy. You will identify agency guidance impacts and drive process improvements for efficiency.

In this role you will lead or support GRA efforts, manage on-time submissions, and liaise with affiliates to publish defined content, ensuring adherence to health authority requirements and established schedules.

Qualifications

• Minimum of 5 years of regulatory operations experience and in-depth first-hand experience with 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 operations

Electronic submissions

Document management systems

Publishing tools

Microsoft Office

SharePoint

NDAs/MAAs experience

Tools

Documentum

DocuBridge

InSight Publisher

GlobalSubmit Validate

GlobalSubmit Review

ISIToolbox

Job description

Otsuka America Pharmaceutical Inc. is seeking a Manager Regulatory Operations to coordinate high-quality regulatory publishing deliverables aligned with program strategy. You will identify agency guidance impacts and drive process improvements for efficiency.

In this role you will lead or support GRA efforts, manage on-time submissions, and liaise with affiliates to publish defined content, ensuring adherence to health authority requirements and established schedules.