The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
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The Associate Director, Global Regulatory Affairs will contribute to the development of US and Global regulatory strategies for Eisai’s next-generation Neurology Portfolio from early development through post approval. This role will require: (1) careful understanding of current Regulatory environment (competitive intelligence and Health Authority guidance), (2) in depth planning with International Project Teams to ensure successful execution of INDs/CTAs/NDAs/MAAs, and most importantly, (3) frequent interactions with global Health Authorities to obtain agreement on the innovative strategies proposed to support getting these products to market expeditiously.
The Associate Director, Global Regulatory Affairs will foster drug development by facilitating the identification and resolution of scientific and regulatory issues with global Health Authorities such as the FDA, EMA and PMDA. The individual who assumes this role must possess the ability to work in a matrix organizational structure, show agility in problem solving and be able to work successfully with all levels of management.
The Associate Director will lead and contribute to the preparation and submission of INDs/CTAs/MAAs/NDAs/BLAs, responses to Healthy Authority requests for information and interact directly with global Health Authorities.
Primary Responsibilities Include but are not limited to:
• Assuming the role of Global Regulatory Lead (GRL) for assigned products in the Neurology Business Group Portfolio. • Leading the planning, execution and assessment of product life cycle management activities from early development through post approval • Proactively formulating regulatory strategies that provide for streamlined development and approval timelines, while accurately interpreting and reflecting regulatory and Corporate guidelines. • Leading the planning, preparation for and conduct of meetings with Health Authorities for all assigned products. Initiating and responding to Health Authority contacts to ensure expedient and efficient review and approval of products. • Leading creation of and ensuring all documents submitted to Health Authorities have been evaluated to ensure that they are complete, well organized, scientifically accurate, of high quality, and are in regulatory compliance as well as presented in a way that facilitates review. • Identifying, monitoring and resolving regulatory issues and reporting progress to management. • Guiding project teams to implement appropriate regulatory strategies and to assess regulatory support needs and align resources as Chair of the Global Regulatory Subteam. • Leading and coordinating all regulatory activities required for submissions to Health Authorities for assigned products.
Education and Skills Requirements:
• B.A./B.S. in the sciences or health related field with an advanced degree preferred • A minimum of 8 years overall pharma experience including 6 years of industry Regulatory Strategy experience required• Demonstrated knowledge of drug development process and strategic thinking skills are essential • Knowledge of US and global regulations and specific Health Authority guidance documents • Experience with preparing IND/CTA submissions and briefing packages for Healthy Authority meetings is essential • Experience with successful NDA, sNDA and/or BLA filings preferred. • Prior experience working with the global Health Authorities is preferred • The ability to bring divergent views together to align on common objectives • The ability to work on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors • The ability to analyze gaps in current work processes and recommend enhancements • Demonstrated ability to solve complex problems • The ability to work within and lead cross-functional team meetings and work streams • Strong written and verbal communication skills • A personality that engenders enthusiasm through challenging circumstances • This role has the potential to manage a direct report based on business needs • Approximately 10% travel based on business needs