Remote Regulatory Submissions Manager

Otsuka America Pharmaceutical Inc.; Des Moines (IA); Remote; USD 108,000 - 161,000; Full time

Benefits offered by this job

Medical coverage

Dental and vision insurance

401(k) match

Paid time off

Job summary

Otsuka America Pharmaceutical Inc. is seeking a Manager of Regulatory Operations to coordinate high-quality, on-time regulatory publishing deliverables in line with program strategy.

You will drive process improvements and serve as a liaison across R&D to ensure compliant electronic submissions. You will oversee submission design, archiving, and quality control, while guiding staff and vendors to meet regulatory requirements.

Qualifications

• Minimum 5 years of regulatory operations experience and hands-on electronic submissions experience.
• Knowledge of FDA/EMA/HC/Swiss Medic regulations and guidance for electronic and paper submissions.
• Expertise in regulatory operations, including formatting, publishing, submitting, lifecycle, and archiving (eCTD) sequences.
• Proven ability to manage time-intensive deliverables.
• Experience with document management systems and publishing tools.
• Strong MS Office and SharePoint skills.
• Recent NDAs/MAAs experience essential.

Responsibilities

• Coordinate regulatory publishing and submissions, providing oversight and leadership.
• Ensure submissions are accurate, on-time, and within budget.
• Lead and coordinate regulatory publishing activities across R&D functions.
• Liaise with affiliates to coordinate and publish content.
• Deliver electronic regulatory submissions meeting health authority requirements.
• Design processes to maximize electronic lifecycle and submissions maintenance.
• Oversee submission archival activities and documentation quality checks.
• Direct staff and contingent workers on quality control for submission documents.
• Manage vendor relationships and project teams for submissions.

Skills

Regulatory publishing

Submission management

GxP regulatory knowledge

Documentation control

Process improvement

Cross-functional liaison

NDAs/MAAs experience

Regulatory strategy awareness

Tools

Documentum

DocuBridge

InSight Publisher

GlobalSubmit Validate

GlobalSubmit Review

ISIToolbox

MS Office (Word/Excel/PowerPoint)

SharePoint

Job description

Otsuka America Pharmaceutical Inc. is seeking a Manager of Regulatory Operations to coordinate high-quality, on-time regulatory publishing deliverables in line with program strategy.

You will drive process improvements and serve as a liaison across R&D to ensure compliant electronic submissions. You will oversee submission design, archiving, and quality control, while guiding staff and vendors to meet regulatory requirements.