Remote Regulatory Submissions & Operations Manager

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

Benefits offered by this job

Comprehensive medical, dental, vision,

401(k) match

Paid holidays and paid leave programs

Job summary

Otsuka America Pharmaceutical Inc. is seeking a Manager of Regulatory Operations to coordinate high-quality regulatory publishing deliverables, align with program strategies, and drive process improvements across submissions.

The role requires expertise with FDA/EMA/HC guidelines, eCTD lifecycles, and leading teams or vendors to ensure on-time submissions and compliant archival. Remote, full-time, with comprehensive benefits.

Qualifications

• Minimum 5 years of regulatory operations experience and in-depth experience with electronic submissions (eCTD).
• Knowledge of FDA/EMA/HC/Swiss Medic regulations and guidance for submissions.
• Expert in regulatory operations, including formatting, publishing, submitting, lifecycling, and archiving (eCTD).
• Experience managing time-intensive deliverables and coordinating with vendors.
• Proficient with Document Management Systems and publishing tools; strong MS Office and SharePoint skills.
• Experience with NDAs/MAAs is essential.

Responsibilities

• Coordinate regulatory publishing and submission assignments, monitoring, and oversight.
• Ensure submissions are on-time, within budgets, and of high quality.
• Liaise with affiliates and internal teams for content publishing and lifecycle maintenance.
• Lead or support regulatory affairs activities and provide direction to staff and contingent workers.
• Oversee project teams for submissions, including vendor collaboration and process mapping.
• Develop and maintain regulatory operations work instructions and best practices.

Skills

Regulatory operations

Regulatory publishing

Project leadership

Education

Bachelor's degree in life sciences

Regulatory affairs certification (RAPS)

Tools

DocuBridge

InSight Publisher

GlobalSubmit Validate

GlobalSubmit Review

ISIToolbox

SharePoint

Microsoft Office (Word, Excel, PowerPoint)

Job description

Otsuka America Pharmaceutical Inc. is seeking a Manager of Regulatory Operations to coordinate high-quality regulatory publishing deliverables, align with program strategies, and drive process improvements across submissions.

The role requires expertise with FDA/EMA/HC guidelines, eCTD lifecycles, and leading teams or vendors to ensure on-time submissions and compliant archival. Remote, full-time, with comprehensive benefits.