Associate Director, Global Labeling

Join Otsuka America Pharmaceutical Inc. as an Associate Director of Global Labeling in Salem, Marion County. In this full-time leadership position, you'll oversee the development and maintenance of labeling materials for pharmaceutical compounds, ensuring accuracy and regulatory compliance across global markets.

About the Role

You'll lead the creation and oversight of worldwide labeling documentation, including clinical summaries, regional packaging materials, and patient information. Working collaboratively with teams throughout the organization, you'll provide strategic guidance on labeling content, review submissions for regulatory adherence, and manage timelines to support product launches and updates.

What You'll Do

• Oversee development and maintenance of labeling materials across global markets for assigned compounds
• Collaborate with regulatory, medical, clinical, and commercial colleagues to align labeling with organizational and compliance objectives
• Deliver strategic recommendations and guidance on labeling content, regulatory requirements, and timelines
• Review labeling submissions and provide feedback to ensure regulatory compliance and accuracy
• Stay current with regulatory changes and adapt labeling approaches as needed
• Maintain documentation of labeling decisions and approvals

What We're Looking For

• Extensive experience in pharmaceutical labeling, regulatory affairs, or related pharmaceutical operations
• Deep knowledge of FDA labeling regulations and international labeling requirements
• Proven ability to lead and collaborate across multiple functional areas
• Excellent written and verbal communication skills
• Strong analytical and organizational capabilities
• Meticulous attention to detail and commitment to regulatory compliance

About Otsuka America Pharmaceutical Inc.

Otsuka America Pharmaceutical Inc. is a pharmaceutical company developing and delivering innovative medicines to improve patient outcomes.

How to Apply

Apply through this listing to be considered for the Associate Director, Global Labeling position in Salem, Marion County.