Regulatory Submissions Leader (Remote)

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

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) match

Paid time off

Job summary

Otsuka America Pharmaceutical Inc. seeks a Manager of Regulatory Operations to coordinate high-quality, on-time regulatory publishing deliverables aligned with program strategy. You will drive process improvements, liaise with affiliates, and oversee electronic submissions to meet health authority requirements and internal schedules.

The role requires expertise in eCTD, document management systems, and publishing tools, with strong leadership and cross-functional collaboration across R&D teams.

Qualifications

• Minimum of 5 years of regulatory operations experience and first-hand experience with electronic submissions
• Knowledge of FDA/EMA/HC/Swiss Medic regulations and guidance for electronic and paper submissions
• Expert knowledge of regulatory operations, including formatting, publishing, submitting, lifecycling, and archiving (eCTD) sequences
• Demonstrated performance in managing and producing time-intensive deliverables
• Experience with Documentum and publishing tools such as DocuBridge, InSight Publisher, GlobalSubmit Validate/Review, ISIToolbox
• Strong computer skills with Microsoft Office suite and SharePoint
• Knowledge developing processes across multiple departments/divisions leveraging technology
• Recent experience with NDAs / MAAs is essential

Responsibilities

• Coordinate regulatory publishing and submission assignments with monitoring and oversight
• Ensure submissions are high quality, on time, and within budgets
• Act as primary liaison for regulatory publishing across R&D functions
• Liaise with affiliates to publish defined content
• Own electronic regulatory submissions to meet health authority requirements and schedules
• Design processes to maximize electronic lifecycle submissions and continuous improvements
• Maintain submission and archival activities
• Provide guidance to staff to ensure quality checks for submissions
• Oversee project team members and vendor partners on submissions
• Lead process mapping teams for regulatory submissions and annual reports
• Develop and maintain regulatory operations work instructions
• Establish collaborative relationships across colleagues

Skills

Regulatory operations

Project management

Vendor coordination

NDAs/MAAs

eCTD submissions

Regulatory publishing

Cross-functional collaboration

Tools

Documentum

DocuBridge

InSight Publisher

GlobalSubmit Validate

GlobalSubmit Review

ISIToolbox

SharePoint

Microsoft Office

Job description

Otsuka America Pharmaceutical Inc. seeks a Manager of Regulatory Operations to coordinate high-quality, on-time regulatory publishing deliverables aligned with program strategy. You will drive process improvements, liaise with affiliates, and oversee electronic submissions to meet health authority requirements and internal schedules.

The role requires expertise in eCTD, document management systems, and publishing tools, with strong leadership and cross-functional collaboration across R&D teams.