Director RA, Global Labeling

Integra Lifesciences Holdings Corporation - Princeton, NJ

Full-time - Senior

Princeton, NJ

Management of Companies and Enterprises

About the position

The Director of Global Regulatory Labeling at Integra LifeSciences is responsible for overseeing the entire lifecycle of product labeling, including prioritization, creation, review, approval, and maintenance of labeling artwork and templates. This role requires a deep understanding of global labeling requirements and the ability to manage a team effectively while ensuring compliance with various regulations. The position involves collaboration across multiple departments to meet business needs and maintain high standards of quality control in labeling activities.

Responsibilities

• Oversee the prioritization, development, revision, and approval of product global labeling.
• Serve as a strategic cross-functional partner working closely with labeling specialists, managers, and project teams.
• Coach and develop direct reports to create a high-performance culture.
• Foster an environment of compliance and integrity by adhering to company policies and legal guidelines.
• Prioritize and oversee the execution of product label artwork using Integra's validated artwork management system (Kallik).
• Create and maintain labeling project tracking tools and dashboards to monitor deliverables.
• Implement training for the labeling organization to ensure expertise and capabilities.
• Collaborate with other functions to integrate and implement electronic labeling artwork management systems across manufacturing sites.
• Coordinate and support labeling production implementation processes with manufacturing sites and vendors.
• Oversee and prioritize the execution of on-demand label print proofs and barcode grading/verification.

Requirements

• Bachelor's degree and 7+ years of experience in regulatory affairs, quality assurance, and/or labeling.
• A minimum of 10 years of experience managing teams or leading program/project management activities.
• Advanced experience managing complex projects and people in a cross-functional environment.
• Excellent attention to detail and organizational skills.
• Experience in regulatory affairs and quality assurance with knowledge of global regulatory labeling requirements.
• Ability to multi-task and problem solve effectively.
• Excellent writing and communication skills, with proficiency in MS Word, Excel, and PowerPoint.
• Strong understanding of product life cycle management requirements.
• Ability to travel domestically and internationally as needed.