Remote Regulatory Submissions Manager

Otsuka America Pharmaceutical Inc.; Little Rock (AR); Remote; USD 110,000 - 150,000; Full time

Job summary

Otsuka America Pharmaceutical Inc. is seeking a Manager Regulatory Operations to coordinate regulatory publishing deliverables across assigned programs, ensuring quality and timely submissions in line with agency guidance.

You will lead or support GRA efforts, liaise with R&D functions and affiliates, and design processes to streamline electronic submissions while maintaining compliance with health authority requirements and internal schedules.

Responsibilities

• 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

Job description

Otsuka America Pharmaceutical Inc. is seeking a Manager Regulatory Operations to coordinate regulatory publishing deliverables across assigned programs, ensuring quality and timely submissions in line with agency guidance.

You will lead or support GRA efforts, liaise with R&D functions and affiliates, and design processes to streamline electronic submissions while maintaining compliance with health authority requirements and internal schedules.