Senior Scientific Director at Prime overseeing scientific work and client communication strategies. Leading high - quality delivery and driving business growth in healthcare communications.
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
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