Manager, Regulatory Operations

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

Remote

Full time

R12920

Job Summary

The Manager Regulatory Operations is responsible for the coordination of high quality and on-time regulatory publishing deliverables in line with the strategic direction of their assigned programs/products, identifies impact of agency guidance updates relevant to submission process, and drives innovative process change for improved efficiency.

Job Description

• As an integral member of Otsuka's regulatory operations team, provides regulatory publishing and submission assignments, monitoring, and oversight, as well as a lead or support for GRA efforts

• Ensures assigned submissions are made with quality, on-time, and within established budgets

• Acts as primary liaison while coordinating regulatory publishing activities for all R&D functions

• Liaise with affiliates for coordinating and publishing defined content

• Owns delivery of electronic regulatory submissions to ensure processes are followed, as well as quality and timelines are met in accordance with health authority requirements and Otsuka leadership established schedules

• Designs and implements processes and systems to maximize electronic lifecycle / maintenance submissions requirements, including a focus on continuous improvements

• Ensures submission and archival activities