Regulatory Operations Manager: Remote Submissions Lead

Otsuka America Pharmaceutical Inc.; Salt Lake City (UT); Remote; USD 108,000 - 161,000; Full time

Benefits offered by this job

Medical

Dental

Vision

401(k) match

Paid time off

Paid holidays

Leave programs

Job summary

Otsuka America Pharmaceutical Inc. is seeking a Manager, Regulatory Operations to coordinate high‑quality regulatory publishing deliverables and ensure on‑time submissions. You will identify impacts of agency guidance updates and drive process improvements across R&D functions.

With a strong background in eCTD submissions and regulatory lifecycle management, you will lead staff and vendor partners to meet regulatory requirements and timelines, while aligning with global standards and budgets.

Qualifications

• 5+ years in regulatory operations with hands-on electronic submissions.
• Knowledge of FDA/EMA/HC/Swissmedic submission regulations (electronic and paper).
• Experience formatting, publishing, submitting, lifecycle, and archiving eCTD sequences.
• Proven track record delivering time‑critical submissions.
• Expert in DMS (Documentum preferred) and publishing tools such as DocuBridge, InSight Publisher, GlobalSubmit.

Responsibilities

• Coordinate regulatory publishing assignments, monitoring, and oversight.
• Ensure submissions are high quality, on time, and within budgets.
• Act as liaison for regulatory publishing across R&D.
• Liaise with affiliates for publishing defined content.
• Own delivery of electronic submissions meeting regulatory timelines.
• Design processes to maximize electronic lifecycle maintenance.
• Ensure submission and archival activities.
• Provide guidance to staff and contractors on submission documents.
• Oversee project team members and vendor partners.
• Lead Process Mapping Teams for submissions and annual reports.
• Develop and maintain work instructions.
• Build collaborative relationships.
• Organize and maintain regulatory files.
• Provide regulatory publishing guidance to other departments.

Skills

Regulatory publishing

GRA coordination

FDA/EMA knowledge

eCTD submission

Project management

Document management

MS Office/SharePoint

NDAs/MAAs

Tools

Documentum

DocuBridge

InSight Publisher

GlobalSubmit

ISIToolbox

Job description

Otsuka America Pharmaceutical Inc. is seeking a Manager, Regulatory Operations to coordinate high‑quality regulatory publishing deliverables and ensure on‑time submissions. You will identify impacts of agency guidance updates and drive process improvements across R&D functions.

With a strong background in eCTD submissions and regulatory lifecycle management, you will lead staff and vendor partners to meet regulatory requirements and timelines, while aligning with global standards and budgets.