Executive Director, Global Regulatory Affairs - Neurology - Eisai Inc.

At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai’s human health care (hhc) mission. We’re a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer’s disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference.  If this is your profile, we want to hear from you.

Job Summary

The Executive Director, Regulatory Affairs will provide leadership and direction for the global regulatory aspects of Eisai’s products under development and post approval research, including the development of regulatory strategies to ensure effective achievement of regulatory/business objectives.

The Executive Director will direct the development and submission of investigational drug applications, product registration dossiers, supplements, amendments, as well as providing strategic product direction to project teams on interacting and negotiating with regulatory agencies in order to expedite approval of pending registration and answers any questions. This includes oversight, guidance, and management of GRS teams responsible for large, late stage development program or for multiple early stage development programs. Using a hands on approach, this position will ensure the completion of all goals and objectives of the Business Group for these programs as related to regulatory submissions and milestones including interactions with Health Authorities. This role requires experience with NDA/BLA, MAA and supplementary applications.

Essential Functions

·   Provide global regulatory leadership in support of the global development, registration, and life-cycle management of products under responsibility.

·   Ensure the efficient, timely and compliant execution of regulatory strategies and programs.

·   Directs and manages a team of regulatory professionals responsible for development of global regulatory strategic plans for new product development, as well as life cycle management of existing products.

·   May serve as the lead regulatory representative on the project team throughout the product lifecycle.

·   Provide senior staff advice and guidance on regulatory issues, especially for US.

·    Responsible for oversight and strategic planning of the meetings with FDA, EMA, PMDA. Provide strategic support for meetings with other Health Authorities the CDE.

·    Actively participates in Health Authority GCP inspections (e.g., FDA, EMA, PMDA) including responding to observations and  development of corrective actions.

·     Keep abreast of changes in the regulatory environment and implement necessary adaptations. 

·     Provide expert opinion, advice and strategic direction on emerging policy & intelligence matters.

·     Ensure continued engagement, development and performance management of staff.

·     Determining timelines and budgets for program activities and report accordingly.

·     Lead and participate in global regulatory initiatives and committees.

 

Qualifications

·     Bachelor's degree and at least 12 years industry experience with a minimum of 10 years direct Regulatory Affairs experience in the biotech/biopharmaceutical industry.

·     Education area of study in a scientific discipline with a Master’s or other advanced degree preferred.

·     Position involves line management responsibility for personnel in US and UK and has both direct and indirect reports.  Demonstrated success in leading and managing teams is required.

·     Experience in the successful prosecution of NDA/BLA, MAA and supplementary applications in essential.

·     Demonstrated track record of interfacing effectively with FDA, EMA and other global regulatory agencies.

·     Experience in managing the preparation of a marketing application (NDA/BLA/MAA) in CTD format for a major market (US, EU, Canada).

·     Strong strategic skills including the ability to make complex decisions and willingness to defend difficult positions.

·     Excellent operational skills including planning, organizing and ability to motivate and lead others.

·     Excellent verbal and written communication skills and comfortable presenting to all levels of an organization including its Senior Management.

·     Strong personal and interpersonal skills, including the ability to relate to and negotiate with others while maintaining composure an acting with integrity and credibility to build trust.

·     Ability to effectively work with a variety of personnel across a matrix organization and work collaboratively with cross functional teams.

·    Sense of urgency and perseverance to achieve results.

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Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status.  Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans.

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