Remote Regulatory Submissions Manager

Otsuka America Pharmaceutical Inc.; Augusta (ME); Remote; USD 108,000 - 161,000; Full time

Job summary

Otsuka America Pharmaceutical Inc. seeks a Manager of Regulatory Operations to coordinate high-quality, on-time regulatory publishing deliverables and to drive process improvements across R&D functions in the US.

The role leads or supports GRA efforts, ensures submissions meet health authority requirements, and collaborates with affiliates to publish defined content while maintaining schedules and budgets.

Qualifications

• Minimum 5 years of regulatory operations experience and direct experience with electronic submissions.
• Knowledge of FDA/EMA/HC/Swiss Medic regulations for electronic and paper submissions.
• Expertise in regulatory operations including formatting, publishing, submitting, lifecycling and archiving (eCTD).
• Proven ability to manage time-intensive deliverables.
• Experience with Documentum and publishing tools such as DocuBridge, InSight Publisher, GlobalSubmit tools.

Responsibilities

• Coordinate regulatory publishing and submission assignments with oversight as needed.
• Ensure submissions are timely, high quality and within budgets.
• Serve as liaison for regulatory publishing across R&D functions.
• Coordinate with affiliates for publishing defined content.
• Deliver electronic regulatory submissions meeting health authority requirements and schedules.
• Design processes to maximize electronic lifecycle/maintenance submissions and continuous improvements.
• Oversee submission activities and quality control of documents for regulatory agencies.
• Lead staff and contingent workers and provide direction for process mapping teams.
• Develop and maintain regulatory operations work instructions.
• Build collaborative relationships and organize regulatory files.

Skills

Regulatory publishing

Regulatory submissions

Time management

MS Office & SharePoint

Project management

Regulatory knowledge (FDA/EMA/HC/Swiss

Tools

Documentum

DocuBridge

InSight Publisher

GlobalSubmit Validate

GlobalSubmit Review

ISIToolbox

Job description

Otsuka America Pharmaceutical Inc. seeks a Manager of Regulatory Operations to coordinate high-quality, on-time regulatory publishing deliverables and to drive process improvements across R&D functions in the US.

The role leads or supports GRA efforts, ensures submissions meet health authority requirements, and collaborates with affiliates to publish defined content while maintaining schedules and budgets.