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 process 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 departments to meet project needs and develop a high-performance labeling team.

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.
• Manage and adhere to all company policies and Legal and Regulatory guidelines.
• Prioritize and oversee the execution of product label artwork utilizing Integra's validated artwork management system (Kallik).
• Create and maintain labeling project tracking tools and dashboards.
• Implement training for the labeling organization to ensure appropriate expertise and capabilities.
• Collaborate with other functions to integrate and implement electronic labeling artwork management system 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, 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 directly managing teams or leading program or project management activities.
• Advanced and proven record 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.
• Excellent writing and communication skills; proficiency in MS Word, Excel, and PowerPoint.
• Strong understanding of product life cycle management requirements.
• Must be able to independently travel via car or airplane to domestic and international locations.