Remote Regulatory Operations Manager — Submissions

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

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.