Global Regulatory Submissions & Publishing Manager

Otsuka Pharmaceutical Co., Ltd; Northern (KY); On-site; USD 108,000 - 161,000; Full time

Benefits offered by this job

Medical, Dental & Vision

401(k) Match

Paid Holidays

Tuition reimbursement

Job summary

Otsuka Pharmaceutical Co., Ltd seeks an experienced Manager of Regulatory Operations to coordinate regulatory publishing deliverables for assigned programs, ensuring on-time submissions and adherence to health authority requirements. This role oversees staff and vendor partners, driving process improvements and maintaining lifecycle submissions.

The candidate will have 5+ years of regulatory operations experience, and deep knowledge of FDA/EMA/HC/Swiss Medic regulations, eCTD formatting,

Qualifications

• Minimum 5 years of regulatory operations experience
• Knowledge of FDA/EMA/HC/Swiss Medic regulations for electronic and paper submissions
• Experience with eCTD sequences, publishing, lifecycling and archiving

Responsibilities

• Coordinate regulatory publishing deliverables for assigned programs and products
• Act as primary liaison for regulatory publishing activities across R&D functions
• Ensure submissions are on time, within budget and comply with health authority requirements
• Provide leadership and guidance to staff and vendors to ensure quality control of submission documents

Skills

Regulatory operations

Project management

Documentation

Cross-functional collaboration

Education

Regulatory Affairs Certification (RAC)

Tools

DocuBridge

InSight Publisher

GlobalSubmit Validate

GlobalSubmit Review

ISIToolbox

Job description

Otsuka Pharmaceutical Co., Ltd seeks an experienced Manager of Regulatory Operations to coordinate regulatory publishing deliverables for assigned programs, ensuring on-time submissions and adherence to health authority requirements. This role oversees staff and vendor partners, driving process improvements and maintaining lifecycle submissions.

The candidate will have 5+ years of regulatory operations experience, and deep knowledge of FDA/EMA/HC/Swiss Medic regulations, eCTD formatting,