Remote Regulatory Operations Manager

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

Benefits offered by this job

Comprehensive medical

Dental

Vision

401(k) match

Paid holidays

Paid leave programs

Job summary

Otsuka America Pharmaceutical Inc. seeks a Manager Regulatory Operations for a remote, full-time role in the United States. You will coordinate regulatory publishing deliverables, ensure on-time submissions, and drive process improvements aligned with agency requirements.

In this role you will lead publishing activities across R&D, liaise with affiliates, manage staff and vendor work, and uphold archival standards and compliance across eCTD submissions.

Qualifications

• Minimum of 5 years in regulatory operations and electronic submissions.
• Knowledge of FDA/EMA/HC/Swiss Medic regulations for eSubmission.
• Experience with formatting, publishing, lifecycling and archiving (eCTD).
• Proven ability to manage time-intensive deliverables.
• Familiarity with regulatory documents and publishing tools.

Responsibilities

• As an integral member, coordinates regulatory publishing assignments and oversight.
• Ensure submissions are on-time, within budgets.
• Lead or support GRA efforts and liaise with affiliates for content.
• Own delivery of electronic regulatory submissions per authority requirements.
• Develop processes to maximize lifecycle submissions and continuous improvements.
• Provide guidance to staff and vendors to ensure quality control for submissions.
• Oversee project team members and vendor partners for submissions.
• Develop and maintain regulatory operations work instructions.
• Build collaborative relationships across functions.

Skills

Regulatory operations

eCTD submissions

Document management

Regulatory publishing tools

NDAs/MAAs familiarity

Cross-functional collaboration

Tools

DocuBridge

InSight Publisher

GlobalSubmit Validate

GlobalSubmit Review

ISIToolbox

Microsoft Office

SharePoint

Job description

Otsuka America Pharmaceutical Inc. seeks a Manager Regulatory Operations for a remote, full-time role in the United States. You will coordinate regulatory publishing deliverables, ensure on-time submissions, and drive process improvements aligned with agency requirements.

In this role you will lead publishing activities across R&D, liaise with affiliates, manage staff and vendor work, and uphold archival standards and compliance across eCTD submissions.