Remote Regulatory Submissions Leader

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

Benefits offered by this job

Medical

Dental

Vision

401(k) match

Tuition reimbursement

Paid holidays

Paid leave

Disability insurance

Life insurance

Job summary

The Manager Regulatory Operations at Otsuka America Pharmaceutical Inc. will coordinate regulatory publishing deliverables aligned with program strategy and agency guidance updates, driving efficiency gains and lifecycle improvements.

You will oversee electronic submissions, engage with R&D and affiliates, and ensure quality, timelines, and compliance with health authority requirements across global programs.

Qualifications

• Minimum of 5 years of regulatory operations experience with hands-on electronic submissions (eCTD).
• Knowledge of FDA/EMA/HC/Swiss Medic regulations and guidance for electronic and paper submissions.
• Expertise in regulatory operations: formatting, publishing, submitting, lifecycling, archiving (eCTD) sequences.
• Experience with Documentum and publishing tools listed in qualifications.
• Strong MS Office and SharePoint skills; ability to lead cross-functional teams.

Responsibilities

• Coordinate regulatory publishing deliverables and submissions to health authorities.
• Ensure on-time submissions within budget and quality standards.
• Liaise with affiliates and R&D functions for publishing content.
• Own electronic submissions delivery and archival activities.
• Provide direction to staff and vendors; lead process mapping and improvements.
• Develop and maintain regulatory operations work instructions and standards.

Tools

Documentum

DocuBridge

InSight Publisher

GlobalSubmit Validate

GlobalSubmit Review

ISIToolbox

MS Office

SharePoint

NDAs/MAAs

Project management

Job description

The Manager Regulatory Operations at Otsuka America Pharmaceutical Inc. will coordinate regulatory publishing deliverables aligned with program strategy and agency guidance updates, driving efficiency gains and lifecycle improvements.

You will oversee electronic submissions, engage with R&D and affiliates, and ensure quality, timelines, and compliance with health authority requirements across global programs.