Regulatory Publishing and Submissions Lead — Remote

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

Job summary

Otsuka America Pharmaceutical Inc. is seeking a Manager Regulatory Operations to coordinate high-quality, on-time regulatory publishing for assigned programs, identify impacts of regulatory guidance, and drive process improvements.

In this role you will lead submissions, liaise with affiliates, manage vendors, and ensure compliance with health authority requirements while guiding staff to deliver accurate, timely regulatory documents.

Qualifications

• Minimum of 5 years of regulatory operations experience.
• First-hand experience with electronic submissions (eCTD).
• Knowledge of FDA/EMA/HC/Swiss Medic regulations.
• Expert knowledge of Document Management Systems (Documentum preferred) and publishing tools.
• Strong MS Office and SharePoint skills.
• NDAs/MAAs experience essential.
• Experience coordinating across departments and vendors.

Responsibilities

• Coordinate regulatory publishing deliverables on time and within budget.
• Lead or support GRA efforts and regulatory submissions.
• Serve as liaison for regulatory publishing across R&D.
• Coordinate with affiliates for content publication.
• Ensure electronic submissions meet health authority requirements.
• Design processes to maximize lifecycle submissions and continuous improvements.
• Oversee staff and vendors to ensure QC of submission documents.
• Provide guidance for Regulatory Submissions and Annual Reports.
• Maintain regulatory work instructions and file organization.

Skills

Regulatory operations

Regulatory publishing

Project management

Cross-functional collaboration

Tools

Documentum

DocuBridge

InSight Publisher

GlobalSubmit Validate

GlobalSubmit Review

ISIToolbox

SharePoint

Microsoft Office

Job description

Otsuka America Pharmaceutical Inc. is seeking a Manager Regulatory Operations to coordinate high-quality, on-time regulatory publishing for assigned programs, identify impacts of regulatory guidance, and drive process improvements.

In this role you will lead submissions, liaise with affiliates, manage vendors, and ensure compliance with health authority requirements while guiding staff to deliver accurate, timely regulatory documents.