Manager, Regulatory Operations

Otsuka America Pharmaceutical Inc.; Baton Rouge (LA); Remote; USD 110,000 - 140,000; Full time

Job summary

Otsuka America Pharmaceutical Inc. is seeking a Manager Regulatory Operations to coordinate high-quality regulatory publishing deliverables and drive process improvements for submissions. This role focuses on ensuring timely, compliant submissions and efficient workflows.

You will lead or support GRA efforts, liaise with R&D affiliates, and manage electronic submissions while adhering to health authority requirements. Strong process improvement skills are essential.

Qualifications

• Experience managing regulatory publishing for submissions.
• Experience coordinating with R&D and affiliates.
• Ability to ensure on-time and within-budget submissions.
• Familiarity with health authority requirements and submission processes.

Responsibilities

• Coordinate regulatory publishing deliverables on-time and within budget.
• Identify impact of agency guidance on submission process.
• Lead or support GRA efforts.
• Liaise with affiliates for publishing content.
• Own delivery of electronic regulatory submissions and ensure timelines.
• Design processes and systems to maximize electronic lifecycle submissions.
• Ensure submission and archival activities.

Skills

Regulatory publishing

Project coordination

Regulatory compliance

Cross-functional collaboration

Process improvement

Education

Bachelor's degree in a life sciences field

Tools

eCTD software

Regulatory submission systems

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