Regulatory Submissions & Publishing Manager - Remote

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

Benefits offered by this job

Medical, dental, vision coverage

401(k) match

Paid time off

Job summary

Otsuka America Pharmaceutical Inc. in the United States is seeking a Manager Regulatory Operations to coordinate regulatory publishing deliverables, ensure on-time submissions, and guide cross-functional teams through eCTD processes.

You will lead or support GRA efforts, liaise with affiliates, supervise staff and vendors, and drive continuous improvements to regulatory lifecycle maintenance. This role demands 5+ years in regulatory operations and knowledge of FDA/EMA submissions and regulatory

Qualifications

• Minimum of 5 years of regulatory operations experience with electronic submissions.
• Knowledge of FDA/EMA/HC/Swiss Medic regulations for electronic and paper submissions.
• Expertise in eCTD sequences and regulatory publishing
• Experience with Document Management Systems and publishing tools
• Proficient with MS Office and SharePoint
• Experience with NDAs/MAAs is essential

Responsibilities

• Coordinate regulatory publishing assignments, monitoring, and oversight.
• Ensure submissions are made on-time and within budgets.
• Act as liaison for regulatory submissions across R&D functions
• Coordinate with affiliates for publishing defined content
• Oversee electronic submission delivery to ensure quality and timelines
• Design processes to maximize electronic lifecycle maintenance submissions
• Maintain regulatory files and provide guidance to departments
• Lead staff and contingent workers to ensure quality checks for submissions
• Manage project teams and vendor relationships
• Support process mapping and annual reporting activities

Skills

Regulatory publishing

Regulatory submissions

Regulatory operations

Documentation management

SharePoint

Microsoft Office

NDAs/MAAs

Process improvement

Tools

DocuBridge

InSight Publisher

GlobalSubmit Validate

GlobalSubmit Review

ISIToolbox

Documentum

Job description

Otsuka America Pharmaceutical Inc. in the United States is seeking a Manager Regulatory Operations to coordinate regulatory publishing deliverables, ensure on-time submissions, and guide cross-functional teams through eCTD processes.

You will lead or support GRA efforts, liaise with affiliates, supervise staff and vendors, and drive continuous improvements to regulatory lifecycle maintenance. This role demands 5+ years in regulatory operations and knowledge of FDA/EMA submissions and regulatory