Remote Regulatory Submissions Manager

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

Benefits offered by this job

Medical, Dental, Vision Insurance

401(k) match

Paid time off

Job summary

Otsuka America Pharmaceutical Inc. is seeking a Manager Regulatory Operations to coordinate high-quality, on-time regulatory publishing deliverables across assigned programs, staying aligned with agency guidance and driving process improvements.

You will lead regulatory publishing assignments, liaise with R&D affiliates, ensure submissions meet health authority requirements, and oversee vendor partners to deliver compliant eCTD submissions.

Qualifications

• Minimum 5 years in regulatory operations with hands-on electronic submissions experience.
• Knowledge of FDA/EMA/HC/Swiss Medic regulations for electronic/paper submissions.
• Expertise in regulatory operations: formatting, publishing, submitting, lifecycle management, archiving (eCTD).
• Proven ability to deliver time-intensive regulatory deliverables on schedule.
• Strong experience with Documentum and publishing tools (DocuBridge, InSight Publisher, GlobalSubmit).
• Proficiency in Microsoft Office and SharePoint; capable of cross‑functional collaboration.
• Experience with NDAs/MAAs is essential.

Responsibilities

• Coordinate regulatory publishing assignments and provide oversight for submissions.
• Ensure submissions are high quality, timely, and within budget.
• Serve as liaison for Regulatory Affairs across R&D functions.
• Liaise with affiliates to publish defined content.
• Deliver electronic regulatory submissions and ensure standards compliance.
• Design processes to optimize electronic lifecycle and maintenance submissions.
• Oversee submission archival activities and quality checks.
• Provide direction to staff and vendors for submission work.
• Lead and participate in Process Mapping Teams for submissions and annual reports.
• Develop and maintain regulatory operations work instructions.

Skills

Regulatory publishing

eCTD submissions

FDA/EMA guidance

Project management

Vendor management

Microsoft Office & SharePoint

NDAs/MAAs experience

Education

Bachelor's degree in life sciences

Tools

Documentum

DocuBridge

InSight Publisher

GlobalSubmit Suite

ISIToolbox

SharePoint

Job description

Otsuka America Pharmaceutical Inc. is seeking a Manager Regulatory Operations to coordinate high-quality, on-time regulatory publishing deliverables across assigned programs, staying aligned with agency guidance and driving process improvements.

You will lead regulatory publishing assignments, liaise with R&D affiliates, ensure submissions meet health authority requirements, and oversee vendor partners to deliver compliant eCTD submissions.