Global Labeling Strategy & Operations Leader

Otsuka Pharmaceutical Co., Ltd; United States; Remote; USD 150,000 - 224,000; Full time

Benefits offered by this job

Comprehensive medical benefits

401(k) match

Paid holidays and PTO

Tuition reimbursement

Job summary

Otsuka America Pharmaceutical Inc. is seeking a labeling professional to support the Global Labeling Lead in developing and maintaining labeling for CCDS and local labeling across products.

You will partner with regulatory teams to ensure labeling alignment, prepare submissions, and contribute to continuous improvements of the end-to-end labeling process. A strong understanding of regulatory requirements and cross-functional teamwork is essential.

Qualifications

• Labeling experience in drug development or regulatory affairs.
• Strong collaboration across cross-functional teams and vendors.

Responsibilities

• Maintain and manage labeling components in compliance with current regulations.
• Support creation and submission of labeling documents (CCDS, Local Labeling, SPL).
• Collaborate with global labeling and cross-functional teams to ensure consistency across documents.
• Support process improvements and inspection readiness related to labeling.

Skills

Labeling

Regulatory affairs

Education

Bachelor’s Degree in a related field

Job description

Otsuka America Pharmaceutical Inc. is seeking a labeling professional to support the Global Labeling Lead in developing and maintaining labeling for CCDS and local labeling across products.

You will partner with regulatory teams to ensure labeling alignment, prepare submissions, and contribute to continuous improvements of the end-to-end labeling process. A strong understanding of regulatory requirements and cross-functional teamwork is essential.