Senior Regulatory Submissions Manager — Remote

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

Benefits offered by this job

Comprehensive benefits

401(k) match

Tuition reimbursement

Paid time off

Job summary

Otsuka America Pharmaceutical Inc. is seeking a Manager Regulatory Operations to coordinate regulatory publishing deliverables, align with submission timelines, and implement process improvements across assigned programs.

You will lead regulatory publishing activities, liaise with affiliates, and guide staff to ensure high-quality electronic submissions in compliance with health authority requirements.

Qualifications

• Minimum of 5 years of regulatory operations experience and first-hand experience with electronic submissions.
• Knowledge of FDA/EMA/HC/Swiss Medic regulations and guidance for submissions.
• Expert knowledge of regulatory operations including formatting, publishing, lifecycling, and archiving (eCTD) sequences.
• Experience managing time-intensive deliverables and leading teams.
• Familiarity with Document Management Systems and publishing tools.

Responsibilities

• Coordinate regulatory publishing assignments, monitoring, and oversight as a lead or support for GRA efforts.
• Ensure submissions are accurate, on-time, and within budgets.
• Serve as liaison for regulatory publishing across R&D functions.
• Liaise with affiliates for content coordination and publishing.
• Oversee delivery of electronic regulatory submissions meeting health authority requirements.

Skills

Regulatory operations

eCTD submissions

Regulatory publishing tools

GRA coordination

Microsoft Office

NDAs/MAAs

Education

Regulatory affairs certification (RAPS)

Tools

Documentum

DocuBridge

InSight Publisher

GlobalSubmit

ISIToolbox

Job description

Otsuka America Pharmaceutical Inc. is seeking a Manager Regulatory Operations to coordinate regulatory publishing deliverables, align with submission timelines, and implement process improvements across assigned programs.

You will lead regulatory publishing activities, liaise with affiliates, and guide staff to ensure high-quality electronic submissions in compliance with health authority requirements.