Remote Regulatory Operations Manager

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

Benefits offered by this job

Medical, dental, vision coverage

401(k) match

Paid time off

Job summary

Otsuka America Pharmaceutical Inc. is seeking a Manager Regulatory Operations to coordinate high-quality, on-time regulatory publishing deliverables in line with program strategy. The role identifies agency guidance impacts, drives process improvements, and leads submissions for R&D functions.

The position requires extensive experience in regulatory operations, eCTD lifecycle management, and coordination with affiliates and vendors, with a focus on timely, compliant electronic submissions.

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.
• Experience with Document Management Systems (Documentum preferred) and publishing tools.
• Strong computer skills with Microsoft Office suite 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

FDA/EMA/HC/Swiss Medic regs

Document management systems

Publishing tools

Microsoft Office & SharePoint

NDAs/MAAs

Tools

Documentum

DocuBridge

InSight Publisher

GlobalSubmit Validate

GlobalSubmit Review

ISIToolbox

Word

Excel

Access

PowerPoint

SharePoint

Job description

Otsuka America Pharmaceutical Inc. is seeking a Manager Regulatory Operations to coordinate high-quality, on-time regulatory publishing deliverables in line with program strategy. The role identifies agency guidance impacts, drives process improvements, and leads submissions for R&D functions.

The position requires extensive experience in regulatory operations, eCTD lifecycle management, and coordination with affiliates and vendors, with a focus on timely, compliant electronic submissions.