Remote Regulatory Submissions Manager

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

Benefits offered by this job

Comprehensive medical

Dental coverage

Vision coverage

401(k) match

Paid holidays

Flexible time off

Job summary

Otsuka America Pharmaceutical Inc. is seeking a Manager, Regulatory Operations to coordinate on-time regulatory publishing deliverables in line with program strategy. You will oversee electronic submissions, ensure quality and budgets, and lead cross-functional teams across R&D and affiliates.

This role emphasizes process improvements, documentation, and compliance with FDA/EMA/regulator requirements, with a remote work option and full-time responsibilities in the United States.

Qualifications

• Minimum of 5 years of regulatory operations experience and hands-on experience with electronic submissions.
• 1-2 lines describing FDA/EMA guidance familiarity.
• Experience with eCTD sequences and lifecycle management.

Responsibilities

• Coordinate regulatory publishing assignments and oversight for submissions.
• Oversee delivery of electronic submissions to health authorities.
• Coordinate with affiliates for content publishing and lifecycle maintenance.
• Provide leadership for process mapping and staff guidance.

Skills

Regulatory submissions

Regulatory operations

Project management

Staff leadership

NDAs/MAAs experience

Microsoft Office

Regulatory landscape knowledge

Education

Bachelor's degree in Life Sciences or related field

Tools

Documentum

DocuBridge

InSight Publisher

GlobalSubmit Suite

ISIToolbox

Job description

Otsuka America Pharmaceutical Inc. is seeking a Manager, Regulatory Operations to coordinate on-time regulatory publishing deliverables in line with program strategy. You will oversee electronic submissions, ensure quality and budgets, and lead cross-functional teams across R&D and affiliates.

This role emphasizes process improvements, documentation, and compliance with FDA/EMA/regulator requirements, with a remote work option and full-time responsibilities in the United States.