Manager, Regulatory Operations

Otsuka America Pharmaceutical Inc.; Lincoln (NE); Remote; USD 110,000 - 160,000; Full time

Job summary

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

You will lead or support GRA efforts, liaise with affiliates, and manage electronic submissions to health authorities, ensuring timelines and budgets are met while maintaining archives and lifecycle maintenance.

Qualifications

• Minimum of 5 years of regulatory operations experience with electronic submissions.
• Knowledge of FDA/EMA/HC/Swiss Medic regulations and guidance for electronic and paper submissions.
• Experience with formatting, publishing, submitting, lifecycling, and archiving (eCTD) sequences.
• Demonstrated performance in managing and producing time-intensive deliverables.
• Expert knowledge of Document Management Systems (Documentum preferred) and publishing tools (DocuBridge, InSight Publisher, GlobalSubmit Validate, GlobalSubmit Review, ISIToolbox).
• Strong computer skills with demonstrated experience and ability in Microsoft Office suite (Word, Excel, Access, and PowerPoint), and SharePoint.
• Knowledge in developing processes across multiple departments/divisions that leverage technology.
• Recent experience with NDAs / MAAs.

Responsibilities

• Provide regulatory publishing and submission assignments, monitoring, and oversight as a lead or support for GRA efforts.
• Ensure submissions are made with quality, on-time, and within budgets.
• Coordinate regulatory publishing activities for R&D functions and liaise with affiliates.
• Own delivery of electronic regulatory submissions per health authority requirements and schedules.
• Design and implement processes to maximize electronic lifecycle/maintenance submissions requirements.
• Ensure submission and archival activities are completed.
• Provide direction to staff to ensure quality control checks of submission documents.
• Oversee project team members and vendor partners on submissions.
• Lead Process Mapping Teams for Regulatory Submissions and Annual Reports.
• Develop and maintain regulatory operations work instructions.
• Build collaborative relationships with colleagues and organize regulatory files.
• Provide regulatory publishing guidance to other departments.

Skills

Regulatory operations

Leadership

Project management

Communication

Tools

DocuBridge

InSight Publisher

GlobalSubmit Validate

GlobalSubmit Review

ISIToolbox

Documentum

SharePoint

MS Office

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

• Provides direction to staff and contingent workers to assure quality control checks of documents intended for submission to regulatory agencies and compliance with electronic regulatory standards

• Oversees project team members for assigned submissions, including work assignments to vendor partners

• Provides leadership and guidance for Process Mapping Teams (e.g., Key stakeholder for Regulatory Submissions, Key stakeholder for Annual Reports)

• Develops and maintains assigned regulatory operations work instructions

• Establishes and builds collaborative relationships with colleagues

• Responsible for organizing and maintaining regulatory files

• Provides regulatory publishing guidance to other departments / functions

Qualifications

Required:

• Minimum of 5 years of regulatory operations experience and in-depth first-hand experience with application electronic submissions

• Knowledge of FDA/EMA/HC/Swiss Medic regulations and guidance for electronic and paper submissions

• Excellent knowledge and experience in regulatory operations, including: formatting, publishing, submitting, lifecycling, and archiving (eCTD) sequences

• Demonstrated performance in managing and producing time-intensive deliverables

• Expert knowledge of Document Management Systems (Documentum preferred) and publishing tools (e.g., DocuBridge, InSight Publisher, GlobalSubmit Validate, GlobalSubmit Review, and ISIToolbox)

• Strong computer skills with demonstrated experience and ability in Microsoft Office suite (Word, Excel, Access, and PowerPoint), and SharePoint

• Knowledge in developing processes across multiple departments/divisions that leverage technology

• Recent experience with NDAs / MAAs