Regulatory Submissions & Publishing Manager (Remote)

Otsuka America Pharmaceutical Inc.; City of Albany (NY); Remote; USD 108,000 - 161,000; Full time

Job summary

Otsuka America Pharmaceutical Inc. is seeking a Manager of Regulatory Operations to coordinate high‑quality regulatory publishing and on‑time submissions across assigned programs.

You will drive process improvements, liaise with R&D functions, and oversee electronic submission delivery in compliance with health authority requirements. The role requires at least 5 years of regulatory operations experience, strong knowledge of eCTD processes, and expertise with publishing tools such as Documentum,

Qualifications

• Minimum 5 years of regulatory operations experience with electronic submissions.
• Knowledge of FDA/EMA/HC/Swiss Medic regulations for electronic and paper submissions.
• Experience in formatting, publishing, submitting, lifecycling, and archiving (eCTD) sequences.
• Proven ability to manage time-intensive deliverables.
• Expert knowledge of Document Management Systems and publishing tools.
• Strong skills in Word, Excel, Access, PowerPoint, and SharePoint.

Responsibilities

• Coordinate regulatory publishing and submission assignments with oversight.
• Ensure submissions are high quality, on-time, and within budget.
• Act as primary liaison for regulatory publishing across R&D functions.
• Coordinate with affiliates to publish defined content.
• Own electronic submissions delivery and ensure QA checks meet regulatory standards.
• Design processes to maximize electronic lifecycle and continuous improvements.
• Maintain submission archives and staff guidance for submission standards.
• Provide direction to staff and contractors to ensure quality checks.
• Oversee project team members and vendor partners on submissions.
• Lead process-mMapping teams and maintain work instructions.
• Build collaborative relationships across departments.

Skills

Regulatory publishing

Regulatory submissions

FDA/EMA knowledge

Project management

Staff leadership

Cross-functional collaboration

Tools

Documentum

DocuBridge

InSight Publisher

GlobalSubmit Validate

GlobalSubmit Review

ISIToolbox

MS Office

SharePoint

Job description

Otsuka America Pharmaceutical Inc. is seeking a Manager of Regulatory Operations to coordinate high‑quality regulatory publishing and on‑time submissions across assigned programs.

You will drive process improvements, liaise with R&D functions, and oversee electronic submission delivery in compliance with health authority requirements. The role requires at least 5 years of regulatory operations experience, strong knowledge of eCTD processes, and expertise with publishing tools such as Documentum,