Remote Regulatory Submissions Manager

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

Job summary

Otsuka America Pharmaceutical Inc. is seeking a Manager Regulatory Operations to coordinate high-quality regulatory publishing deliverables, aligning with the strategic direction of assigned programs and driving process improvements.

This remote, full-time role supports GRA efforts and ensures submissions meet health authority requirements. The role requires 5+ years in regulatory operations, strong eCTD and document management knowledge, and experience with NDAs/MAAs.

Qualifications

• Minimum of 5 years of regulatory operations experience and first-hand experience with electronic submissions.
• Knowledge of FDA/EMA/HC/Swiss Medic regulations and guidance for electronic and paper submissions.
• Expert knowledge of regulatory operations, including: formatting, publishing, submitting, lifecycling, and archiving (eCTD) sequences.
• NDAs/MAAs experience is essential.

Responsibilities

• Coordinate regulatory publishing assignments, monitoring, and oversight as a lead or support for GRA efforts.
• Ensure submissions are produced with quality, on-time and within budgets.
• Liaise with affiliates for coordinating and publishing defined content.
• Own delivery of electronic regulatory submissions ensuring processes, quality and timelines meet requirements.
• Design and implement processes to maximize electronic lifecycle submissions.
• Provide direction to staff and contingent workers for submission quality controls.
• Oversee project team members for submissions, including vendor coordination.
• Develop and maintain regulatory operations work instructions.

Skills

Regulatory operations

Regulatory submissions

eCTD

Document management systems

GRA processes

Tools

DocuBridge

InSight Publisher

GlobalSubmit Validate

GlobalSubmit Review

ISIToolbox

Documentum

Job description

Otsuka America Pharmaceutical Inc. is seeking a Manager Regulatory Operations to coordinate high-quality regulatory publishing deliverables, aligning with the strategic direction of assigned programs and driving process improvements.

This remote, full-time role supports GRA efforts and ensures submissions meet health authority requirements. The role requires 5+ years in regulatory operations, strong eCTD and document management knowledge, and experience with NDAs/MAAs.