Global Labeling Operations Leader

Otsuka Pharmaceutical Companies (U.S.); United States; On-site; USD 120,000 - 170,000; Full time

Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

401(k) match

Paid holidays

Paid leave

Job summary

Otsuka Pharmaceutical Companies (U.S.) is seeking a labeling professional to support development and lifecycle management of CCDS and local labeling, working with the Global Labeling Lead and regulatory teams. This role collaborates with worldwide Otsuka colleagues, alliance partners, and cross-functional teams to ensure compliant, publication-ready labeling and timely submissions.

The ideal candidate will have strong proofreading/editing skills, experience with regulatory documentation, and the

Qualifications

• Bachelor’s Degree plus at least 5–6 years of labeling experience in drug development.
• Experience with electronic document management systems and electronic submissions.

Responsibilities

• Maintain labeling components according to laws and regulations.
• Ensure labeling formatting and quality requirements met; monitor impact on labeling.
• Suggest improvements to labeling policies, processes, and tools.
• Track labeling changes for assigned regions; monitor compliance metrics.
• Review labeling processes and act as SMEs when new labeling tech is evaluated.

Skills

US labeling regulations

Attention to detail

Communication skills

Problem solving

Document management systems

Proofreading

Education

Bachelor’s Degree in life sciences or related field

Tools

Documentum

RIMS

XML-based QA

Job description

Otsuka Pharmaceutical Companies (U.S.) is seeking a labeling professional to support development and lifecycle management of CCDS and local labeling, working with the Global Labeling Lead and regulatory teams. This role collaborates with worldwide Otsuka colleagues, alliance partners, and cross-functional teams to ensure compliant, publication-ready labeling and timely submissions.

The ideal candidate will have strong proofreading/editing skills, experience with regulatory documentation, and the