Regulatory Submissions & Publishing Lead

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

Benefits offered by this job

Medical, dental, vision coverage

401(k) match

Paid time off

Disability insurance

Life insurance

Tuition reimbursement

Job summary

Otsuka America Pharmaceutical Inc. is seeking a Manager Regulatory Operations to coordinate high-quality regulatory publishing deliverables in line with program strategy.

You will oversee submissions, liaise with affiliates, and ensure timelines and budgets are met. The role emphasizes designing processes for electronic submissions, maintaining lifecycle submissions, and guiding staff and vendors in compliance with regulatory standards.

Qualifications

• Minimum of 5 years of regulatory operations experience and in-depth first-hand experience with electronic submissions.
• Knowledge of FDA/EMA/HC/Swiss Medic regulations and guidance for electronic and paper submissions.
• Expert knowledge of regulatory operations, including formatting, publishing, submitting, lifecycling, and archiving (eCTD) sequences.
• Proven ability to manage time-intensive deliverables and budgets.
• Experience with Document Management Systems and publishing tools listed above.
• Strong PC skills with Word, Excel, PowerPoint, Access and SharePoint.
• Experience with NDAs / MAAs is essential.

Responsibilities

• Coordinate regulatory publishing deliverables and ensure on-time submissions.
• Act as liaison for regulatory publishing activities across R&D functions.
• Liaise with affiliates to coordinate and publish defined content.
• Own delivery of electronic regulatory submissions and ensure compliance with health authority requirements.
• Design and implement processes to maximize electronic lifecycle submissions and continuous improvement.
• Ensure submission and archival activities are completed and documented.
• Provide direction to staff and contingent workers for quality checks on submission documents.
• Oversee project teams, including vendor partners, for assigned submissions.
• Guide Process Mapping Teams and maintain work instructions.
• Build collaborative relationships and manage regulatory files.

Skills

Regulatory submissions

Regulatory operations

Document Management Systems

Regulatory publishing

Vendor coordination

NDAs / MAAs

Microsoft Office & SharePoint

Process improvement

Tools

Documentum

DocuBridge

InSight Publisher

GlobalSubmit Validate

GlobalSubmit Review

ISIToolbox

Job description

Otsuka America Pharmaceutical Inc. is seeking a Manager Regulatory Operations to coordinate high-quality regulatory publishing deliverables in line with program strategy.

You will oversee submissions, liaise with affiliates, and ensure timelines and budgets are met. The role emphasizes designing processes for electronic submissions, maintaining lifecycle submissions, and guiding staff and vendors in compliance with regulatory standards.