Remote Regulatory Submissions Leader

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

Benefits offered by this job

Comprehensive benefits package

401(k) match

Paid time off

Job summary

Otsuka America Pharmaceutical Inc. is seeking a Manager of Regulatory Operations to coordinate high-quality regulatory publishing deliverables and ensure on-time submissions aligned with program strategy.

In this remote, full-time role, you will lead and support GRA initiatives, liaise with affiliates, and drive process improvements across electronic lifecycle submissions while maintaining compliance with health authority requirements.

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 regulatory operations, provide regulatory publishing and submission assignments, monitoring, and oversight, with lead or support for GRA efforts.
• Ensure submissions are made with quality, on-time, and within budgets.
• Act as primary liaison coordinating regulatory publishing activities for all R&D functions.
• Liaise with affiliates for coordinating and publishing defined content.
• Own delivery of electronic regulatory submissions to ensure processes, quality and timelines meet health authority requirements and Otsuka schedules.
• Design and implement processes to maximize electronic lifecycle submissions and continuous improvements.
• Ensure submission and archival activities are completed.
• Provide direction to staff and contingent workers for quality control of submission documents.
• Oversee project team members for submissions, including vendor coordination.
• Provide leadership for Process Mapping Teams (Reg Submissions, Annual Reports).
• Develop and maintain regulatory operations work instructions.
• Establish and build collaborative relationships with colleagues.
• Responsible for organizing and maintaining regulatory files.
• Provide regulatory publishing guidance to other departments.

Skills

Regulatory submissions

Regulatory publishing

FDA/EMA knowledge

Document management

DocuBridge

InSight Publisher

GlobalSubmit tools

MS Office

SharePoint

NDAs MAAs

Tools

Documentum

DocuBridge

InSight Publisher

GlobalSubmit Validate

GlobalSubmit Review

ISIToolbox

MS Office

SharePoint

Job description

Otsuka America Pharmaceutical Inc. is seeking a Manager of Regulatory Operations to coordinate high-quality regulatory publishing deliverables and ensure on-time submissions aligned with program strategy.

In this remote, full-time role, you will lead and support GRA initiatives, liaise with affiliates, and drive process improvements across electronic lifecycle submissions while maintaining compliance with health authority requirements.