Remote Regulatory Submissions Leader

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

Benefits offered by this job

401(k) match

Comprehensive medical, dental, vision

Job summary

Otsuka America Pharmaceutical Inc. seeks a Manager Regulatory Operations to coordinate high-quality regulatory publishing deliverables, drive process changes, and align with agency guidance for submissions.

You will lead publishing activities, liaise with R&D and affiliates, and ensure on-time electronic submissions while maintaining budgets and compliance with health authority requirements.

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 formatting, publishing, submitting, lifecycling, and archiving (eCTD) sequences.
• Proven ability to manage time-intensive deliverables and budgets.
• Experience with Documentum and publishing tools such as DocuBridge, InSight Publisher, GlobalSubmit.
• Strong MS Office and SharePoint skills; cross-department process development.
• Recent experience with NDAs/MAAs is essential.

Responsibilities

• Coordinate regulatory publishing and submission assignments with oversight.
• Ensure submissions are on-time, within budgets, and of high quality.
• Serve as liaison for regulatory publishing across R&D functions.
• Collaborate with affiliates to publish defined content.
• Own electronic submissions delivery and ensure compliance with health authority requirements.
• Design processes to maximize electronic lifecycle submissions and continuous improvements.
• Maintain regulatory files and provide guidance to other departments.

Skills

Regulatory operations

eCTD submissions

GxP documentation

Project management

Vendor coordination

MS Office & SharePoint

NDAs & MAAs

Tools

Documentum

DocuBridge

InSight Publisher

GlobalSubmit Validate

GlobalSubmit Review

ISIToolbox

Job description

Otsuka America Pharmaceutical Inc. seeks a Manager Regulatory Operations to coordinate high-quality regulatory publishing deliverables, drive process changes, and align with agency guidance for submissions.

You will lead publishing activities, liaise with R&D and affiliates, and ensure on-time electronic submissions while maintaining budgets and compliance with health authority requirements.