Global Labeling Operations Lead

Otsuka; United States; Remote; USD 150,000 - 224,000; Full time

Benefits offered by this job

Medical, dental, vision

401(k) match

Paid holidays

Flexible time off

Tuition reimbursement

Job summary

Otsuka America Pharmaceutical Inc. seeks a skilled Regulatory Labeling Specialist to support CCDS/local labeling, manage labeling in artwork, and ensure regulatory compliance across regions.

You will collaborate with global teams and external partners, coordinate updates, and contribute to SPL submissions while maintaining audit readiness. The role requires a Bachelor’s degree and 5–6 years of labeling experience in drug development, with strong proofreading, IT skills, and knowledge of

Qualifications

• Bachelor’s degree and 5–6 years labeling for drug development.
• Experience with electronic submission and document management systems.
• Ability to work in cross-functional teams and ensure regulatory alignment.

Responsibilities

• Maintains labeling components per laws and regulations.
• Ensures formatting and quality requirements are met and updated.
• Suggests improvements to labeling policies and processes.
• Tracks labeling changes for assigned regions.
• Monitors end-to-end labeling compliance metrics.
• Act as labeling operations SME for new labeling tech/systems.

Skills

Labeling compliance

Attention to detail

Proofreading

Excellent communication

Cross-functional collaboration

Project management

IT systems proficiency

Education

Bachelor’s Degree

Tools

Documentum

EDMS

RIMS

XML QC

Job description

Otsuka America Pharmaceutical Inc. seeks a skilled Regulatory Labeling Specialist to support CCDS/local labeling, manage labeling in artwork, and ensure regulatory compliance across regions.

You will collaborate with global teams and external partners, coordinate updates, and contribute to SPL submissions while maintaining audit readiness. The role requires a Bachelor’s degree and 5–6 years of labeling experience in drug development, with strong proofreading, IT skills, and knowledge of