Vice President, Global Regulatory Affairs – Neurology
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.
The Vice President Global Regulatory Affairs will be responsible for identifying and implementing company regulatory strategies for the Global Neurology portfolio and other therapy areas, as well as standards in alignment with short and long term business plans. Using a hands on approach, this position will ensure the completion of all goals and objectives of NBG as related to regulatory submissions and milestones, and clinical strategies and trials. The VP is responsible for leading the activities for NBG Regulatory Affairs with emphasis on regulatory strategy and the preparation, review and evaluation of documents for FDA, EMEA, and PMDA submission. Position will provide leadership and direction for the global regulatory aspects of Eisai’s Neurology products under development and post approval research, including developing long and short-term planning of regulatory programs that align with Eisai’s business plan, and develop strategies to ensure effective achievement of regulatory/business objectives. Experience in the successful prosecution of NDA, MAA and supplementary applications is essential. Primary responsibility for interaction with global regulatory bodies for the registration of new products for a therapeutic area. The VP is responsible for compliance with all regulatory requirements and integration of the department into the overall corporate objectives, plans and programs. The VP will be responsible for managing respective functional areas to address the needs of Eisai’s clients, stakeholders, industry groups and employees in an ethical manner. The VP is responsible for oversight of Neurology Global Regulatory Affairs staff and resources including Commercial Regulatory Affairs for Neurology and Oncology.
Provide global regulatory leadership in support of the global development, registration, and life-cycle management of products under responsibility.
Responsible for oversight of the health agency meetings (FDA, EMEA, PMDA, etc) and strategic planning.
Provides leadership in support of Commercial Regulatory Affairs (CoRA)for NBG and the Oncology Business Group and strategic input into the review and approval of effective yet FDA compliant commercial (advertising and promotion) campaigns and pre-commercialization activities.
Provide senior staff advice and guidance on regulatory issues. Keep abreast of changes in the regulatory environment and implement necessary adaptations. Provide expert opinion, advice and strategic direction on emerging policy and intelligence matters, particularly in the priority review space.
Provide regulatory due diligence assessments of new business opportunities as required.
Review major stage deliverables for programs including risk assessment at critical points and ensure the efficient, timely and compliant execution of regulatory strategies and programs.
Pro-actively influence and manage worldwide regulatory agencies to build consensus and ensure Eisai regulatory strategies are implemented on a global basis.
Maintain liaison with all government agencies regulating research and development. Assure that these agencies gain a clearer understanding of and confidence in, our research objectives, procedures and results.
Represent Eisai to outside Regulators, Key Opinion Leaders, Investigations, CROs and vendors.
Bachelor’s degree and at least 10 years industry experience with a minimum of 12 years direct Regulatory Affairs experience in the biotech/biopharmaceutical industry with Neuroscience experience
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. Experience with direct reports is required.
Minimum of 5 years in a senior leadership role managing a large internal group
Experience in the successful prosecution of NDA, MAA and supplementary applications in essential.
Experience in multiple levels of health authority meetings (pre-IND, end of phase 2, pre-NDA, scientific guidance, rapporteur/co-rapporteur) is required.
Experience leading a Commercial Regulatory Affairs team
Experience in managing the preparation of a marketing application (NDA/BLA/MAA) in CTD format for a major market (US, EU, Canada).
Direct interaction/negotiation with regulatory authorities (e.g. FDA, CHMP, PMDA)
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 deal effectively with a variety of personnel across a matrix organization
Sense of urgency and perseverance to achieve results
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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At Eisai Inc., human health care (hhc) is our goal. We give our first thoughts to patients and their families, and helping to increase the benefits health care provides. As the U.S. pharmaceutical subsidiary of Tokyo-based Eisai Co., Ltd., we have a passionate commitment to patient care that is the driving force behind our efforts to discover and develop innovative therapies to help address unmet medical needs.
Eisai is a fully integrated pharmaceutical business that operates in two global business groups: oncology and neurology (dementia-related diseases and neurodegenerative diseases). Our U.S. headquarters, commercial and clinical development organizations are located in New Jersey; our discovery labs are in Massachusetts and Pennsylvania; and our global demand chain organization resides in Maryland and North Carolina. To learn more about Eisai Inc., please visit us at www.eisai.com/US
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Job posted: 2021-09-06