Hybrid Director, Global Labeling

at Cision

• Job title: Director, Global Labeling
• Job type: Full Time
• Experience level: Lead
• Salary: $180,700 - $237,200 per year
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, Bethesda, United States

About the role

• Director, Global Labeling overseeing pharmaceutical regulatory labeling strategies at Eisai. Managing teams in the US and UK to ensure compliance and efficiency in labeling operations.

Responsibilities

• Responsible for the leadership and oversight of the Labeling function within Global Regulatory Services and Operations (GRSO)
• Manage labeling operations and actively contribute to the development and implementation of regulatory labeling strategy and documentation
• Serve as an expert on regulations governing labeling of pharmaceutical products globally
• Manage a team of professionals located in the US and UK
• Develop and mentor direct reports on operational and strategic aspects of labeling
• Ensure consistency of labeling across product lines and compliance with Eisai policies and procedures and applicable regulatory authority directives and regulations

Requirements

• Bachelors degree in life sciences required; higher degree preferred
• Minimum of 10 years of experience in Regulatory, R&D or related area
• Pharmaceutical experience required
• Solid working knowledge of drug development process
• Solid working knowledge and experience of global regulatory labeling environments and requirements
• Solid knowledge of and demonstrated ability to apply regulatory guidelines pertaining to product labeling and ICH guidelines.
• Strong project management, people management, problem solving, strategic thinking, negotiation, interpersonal and communication skills (written and oral)
• Ability to work under tight timelines
• Attention to detail

Benefits

• Eisai Inc. Annual Incentive Plan
• Eisai Inc. Long Term Incentive Plan
• Company employee benefit programs
• Reasonable accommodations for disabilities