Remote Regulatory Submissions Manager

Otsuka America Pharmaceutical Inc.; Tallahassee (FL); Remote; USD 120,000 - 160,000; Full time

Job summary

Otsuka America Pharmaceutical Inc. in the United States seeks a Manager Regulatory Operations to coordinate high-quality regulatory publishing deliverables, align with regulatory strategy, and drive process improvements across assigned programs.

You will lead submissions, monitor timelines, liaise with R&D and affiliates, ensure compliance with health authority requirements, and deliver timely electronic submissions while optimizing lifecycle processes.

Qualifications

• Experience in regulatory publishing and submissions management.
• Strong liaison skills with R&D and affiliates.
• Ability to implement process improvements and maintain timelines.

Responsibilities

• Coordinate regulatory publishing assignments, monitoring, and oversight.
• Ensure submissions are on-time, within budget, and of high quality.
• Act as liaison coordinating regulatory publishing for all R&D functions.
• Liaise with affiliates to publish defined content.
• Own delivery of electronic regulatory submissions per health authority requirements and schedules.
• Design and implement processes to maximise electronic lifecycle submissions and continuous improvements.
• Ensure submission and archival activities.

Job description

Otsuka America Pharmaceutical Inc. in the United States seeks a Manager Regulatory Operations to coordinate high-quality regulatory publishing deliverables, align with regulatory strategy, and drive process improvements across assigned programs.

You will lead submissions, monitor timelines, liaise with R&D and affiliates, ensure compliance with health authority requirements, and deliver timely electronic submissions while optimizing lifecycle processes.