Remote Regulatory Submissions Manager

Otsuka America Pharmaceutical Inc.; Santa Fe (NM); Remote; USD 108,000 - 161,000; Full time

Job summary

Otsuka America Pharmaceutical Inc. seeks a Manager of Regulatory Operations to coordinate high‑quality regulatory publishing deliverables aligned with program strategy. You will identify agency guidance impacts and drive process improvements to boost efficiency.

Responsibilities include leading submissions, liaising with affiliates, and guiding staff to ensure timely electronic submissions across R&D, with strong emphasis on eCTD and lifecycle management.

Qualifications

• 5+ years in regulatory operations and electronic submissions.
• Knowledge of FDA/EMA/HC/Swiss Medic guidelines for submissions.
• Experience with formatting, publishing, lifecycling and archiving (eCTD).
• Proven ability to deliver time-sensitive content and meet timelines.
• Expert with Documentum and publishing tools (DocuBridge, InSight, GlobalSubmit).
• Strong MS Office and SharePoint skills; capable with cross‑functional teams.
• Familiarity with NDAs/MAAs and process improvements.

Responsibilities

• Coordinate regulatory publishing and submission activities across R&D.
• Ensure on-time, high-quality submissions within budgets.
• Liaise with affiliates and vendors for defined content delivery.
• Lead or support GRA efforts and provide staff direction.
• Develop and maintain regulatory operations work instructions.
• Oversee project teams and ensure compliant lifecycle submissions.
• Establish collaborative relationships and ensure archival activities.

Skills

Regulatory operations

Submissions (eCTD)

Document management systems

Publishing tools

NDAs MAAs

Cross-functional teams

Microsoft Office

Process improvement

Tools

DocuBridge

InSight Publisher

GlobalSubmit Validate

GlobalSubmit Review

ISIToolbox

Documentum

Job description

Otsuka America Pharmaceutical Inc. seeks a Manager of Regulatory Operations to coordinate high‑quality regulatory publishing deliverables aligned with program strategy. You will identify agency guidance impacts and drive process improvements to boost efficiency.

Responsibilities include leading submissions, liaising with affiliates, and guiding staff to ensure timely electronic submissions across R&D, with strong emphasis on eCTD and lifecycle management.