Regulatory Submissions Leader — Publishing & eCTD

Otsuka Pharmaceutical Companies (U.S.); United States; On-site; USD 108,000 - 161,000; Full time

Benefits offered by this job

401(k) match

Tuition reimbursement

Paid holidays

Paid leave programs

Job summary

Otsuka Pharmaceutical Companies (U.S.) is seeking a Manager of Regulatory Operations to coordinate high-quality regulatory publishing deliverables in line with program strategy. The role drives process improvements, liaises with R&D functions, and ensures timely electronic submissions in compliance with FDA/EMA/HC/Swiss Medic guidelines.

The position requires leadership in document management systems and publishing tools, with focus on lifecycle maintenance and archival activities across global

Qualifications

• Minimum of 5 years in regulatory operations with hands-on electronic submissions.
• Knowledge of FDA/EMA/HC/Swiss Medic regulations and guidelines for submissions.
• Expert in regulatory operations: formatting, publishing, lifecycling, archiving (eCTD).
• Experience managing time-intensive deliverables.
• Strong familiarity with Documentum and publishing tools.
• Proficient in MS Office and SharePoint.
• Experience with NDAs/MAAs is essential.

Responsibilities

• Coordinate regulatory publishing and submission assignments.
• Ensure on-time, within-budget submissions with quality.
• Lead or support GRA efforts and liaison for R&D functions.
• Coordinate publishing with affiliates and vendor partners.
• Deliver electronic regulatory submissions per health authority requirements.
• Design processes to optimize electronic lifecycle submissions and continuous improvements.
• Oversee submission activities, including archives and staff guidance.
• Develop work instructions and build cross-department collaboration.

Skills

Regulatory publishing

FDA/EMA/HC/Swiss Medic

eCTD knowledge

Documentum

DocuBridge

InSight Publisher

GlobalSubmitValidate

GlobalSubmitReview

ISIToolbox

MS Office & SharePoint

NDAs/MAAs

Tools

Documentum

DocuBridge

InSight Publisher

GlobalSubmit Validate

GlobalSubmit Review

ISIToolbox

Microsoft Office

SharePoint

Job description

Otsuka Pharmaceutical Companies (U.S.) is seeking a Manager of Regulatory Operations to coordinate high-quality regulatory publishing deliverables in line with program strategy. The role drives process improvements, liaises with R&D functions, and ensures timely electronic submissions in compliance with FDA/EMA/HC/Swiss Medic guidelines.

The position requires leadership in document management systems and publishing tools, with focus on lifecycle maintenance and archival activities across global