Senior Remote Regulatory Submissions Lead

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

Benefits offered by this job

Comprehensive medical/dental/vision

401(k) match

Paid holidays and paid leave

Tuition reimbursement

Student loan assistance

Job summary

Otsuka America Pharmaceutical Inc. is seeking a Manager of Regulatory Operations to oversee regulatory publishing, submissions, and lifecycle management for assigned programs worldwide.

This role coordinates with R&D, affiliates, and vendors to ensure timely, compliant deliverables and continuous process improvements. The ideal candidate brings 5+ years in regulatory operations, strong knowledge of FDA/EMA requirements, and expertise in eCTD, DocuBridge, and GlobalSubmit tools.

Qualifications

• Minimum of 5 years of regulatory operations experience with electronic submissions.
• Knowledge of FDA/EMA/HC/Swiss Medic regulations and guidance.
• Expert knowledge of eCTD sequences and archiving.
• Experience with regulatory publishing tools and lifecycle management.
• NDAs/MAAs knowledge and preferred regulatory certifications.

Responsibilities

• Coordinate regulatory publishing and submission assignments with oversight.
• Ensure submissions are on-time, within budgets, and compliant with standards.
• Liaise with affiliates for publishing defined content.
• Own electronic regulatory submissions delivery and timelines.
• Design processes to maximize electronic lifecycle submissions and improvements.
• Provide leadership to staff and vendors; supervise project teams.
• Develop and maintain regulatory operations work instructions.

Skills

Regulatory operations

Electronic submissions

Project coordination

Staff leadership

Process improvement

Documentation management

Education

Regulatory Affairs Certification (RAPS)

Tools

Documentum

DocuBridge

InSight Publisher

GlobalSubmit Validate

GlobalSubmit Review

ISIToolbox

SharePoint

Microsoft Office

Job description

Otsuka America Pharmaceutical Inc. is seeking a Manager of Regulatory Operations to oversee regulatory publishing, submissions, and lifecycle management for assigned programs worldwide.

This role coordinates with R&D, affiliates, and vendors to ensure timely, compliant deliverables and continuous process improvements. The ideal candidate brings 5+ years in regulatory operations, strong knowledge of FDA/EMA requirements, and expertise in eCTD, DocuBridge, and GlobalSubmit tools.