Director, Global Labeling

This is a fully remote position, open to applicants in United States.

📋 Description

• Design and implement global regulatory labeling strategies that align with business goals and address patient needs.

• Supervise direct product responsibilities along with a team of Labeling Strategists.

• Create and uphold labeling documents for the US, EU, Growth, and Rest of World markets.

• Lead cross-functional teams in developing content for new or updated CCDS, USPI, EU SmPC, and other market-specific labels.

• Act as a liaison between co-promote partners and Eisai stakeholders.

• Establish and uphold global labeling processes and standards.

• Operationalize labeling activities across various products.

• Maintain the centralized global labeling repository within Eisai’s electronic document management system.

• Oversee the development, review, and approval workflows for labeling.

• Monitor timely and consistent implementation of safety modifications in local labels.

• Provide labeling support for US and EU Packaging Engineering regarding artwork control and approvals.

• Ensure uniformity and regulatory compliance across all product labeling.

• Analyze competitor labeling to ensure Eisai product labeling remains competitive.

• Maintain expertise in global labeling requirements and relevant regulatory guidelines.

• Represent global regulatory labeling on international project teams and offer strategic input for TPP, CCDS, USPI, EU SmPC, and Country Product Information development and approvals.

• Support resource management, performance management, coaching, mentoring, and professional development for labeling professionals in the US and UK.

⛳️ Requirements

• A Bachelor's degree in life sciences is required.

• A higher degree is preferred.

• A minimum of 10 years of experience in Regulatory, R&D, or related fields is required.

• Experience in the pharmaceutical industry is essential.

• Strong working knowledge of the drug development process is required.

• Extensive knowledge and experience of global regulatory labeling environments and requirements are necessary.

• Proven ability to apply regulatory guidelines related to product labeling effectively.

• Excellent project management, people management, problem-solving, strategic thinking, negotiation, interpersonal, and communication skills are essential.

• Must be able to work under tight deadlines and perform well under pressure.

• Strong attention to detail and the ability to articulate findings are critical.

🏝️ Benefits

• Eligibility for the Annual Incentive Plan.

• Eligibility for the Long Term Incentive Plan.

• Access to company employee benefit programs.

• Additional benefits may be available.

• Support for equal opportunity and disability accommodation.