Eisai US
Executive Director, Global Regulatory Affairs - Neurology
Eisai US, Nutley, New Jersey, us, 07110
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. This includes the development of regulatory strategies to ensure effective achievement of regulatory/business objectives, directing the development and submission of investigational drug applications, registration dossiers, supplements, and amendments, and providing strategic product direction to project teams on interacting and negotiating with regulatory agencies to expedite approval of pending registrations and answer any questions.
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.
Direct and manage a team of regulatory professionals responsible for the development of global regulatory strategic plans for new product development, as well as life‑cycle management of existing products.
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 the U.S.
Oversee and strategically plan meetings with FDA, EMA, PMDA, and other Health Authorities.
Actively participate in Health Authority GCP inspections, respond to observations, and develop corrective actions.
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.
Ensure continued engagement, development, and performance management of staff.
Determine 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 of industry experience with a minimum of 10 years of direct Regulatory Affairs experience in the biotech/biopharmaceutical industry.
Scientific discipline education with a master’s or other advanced degree preferred.
Line‑management responsibility for personnel in the U.S. and U.K.; demonstrated success in leading and managing teams.
Experience in the successful prosecution of NDA/BLA, MAA and supplementary applications.
Track record of interfacing effectively with FDA, EMA, and other global regulatory agencies.
Experience preparing marketing applications (NDA/BLA/MAA) in CTD format for major markets (U.S., EU, Canada).
Strong strategic skills, ability to make complex decisions, and willingness to defend difficult positions.
Excellent operational, planning, organizing, and motivation skills.
Exceptional verbal and written communication skills, comfortable presenting to all levels of an organization including senior management.
Strong interpersonal skills, maintaining composure, integrity, and credibility to build trust.
Ability to work collaboratively across a matrix organization and with cross‑functional teams.
Sense of urgency and perseverance to achieve results.
Salary and Benefits The base salary range for the Executive Director, Global Regulatory Affairs - Neurology is $272,200 - $357,300. The position is eligible to participate in Eisai Inc. Annual Incentive Plan & Eisai Inc. Long‑Term Incentive Plan. Employees are eligible to participate in company employee benefit programs. For additional information on company employee benefits programs, visit
https://us.eisai.com/careers-at-eisai/benefits .
Equal Opportunity Employer Eisai is an equal opportunity employer and is committed to recruiting, hiring, training, and promoting 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. Eisai prohibits discrimination against persons because of disability, including disabled veterans. Eisai participates in E‑Verify. For more information, please review the E‑Verify Participation notice.
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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.
Direct and manage a team of regulatory professionals responsible for the development of global regulatory strategic plans for new product development, as well as life‑cycle management of existing products.
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 the U.S.
Oversee and strategically plan meetings with FDA, EMA, PMDA, and other Health Authorities.
Actively participate in Health Authority GCP inspections, respond to observations, and develop corrective actions.
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.
Ensure continued engagement, development, and performance management of staff.
Determine 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 of industry experience with a minimum of 10 years of direct Regulatory Affairs experience in the biotech/biopharmaceutical industry.
Scientific discipline education with a master’s or other advanced degree preferred.
Line‑management responsibility for personnel in the U.S. and U.K.; demonstrated success in leading and managing teams.
Experience in the successful prosecution of NDA/BLA, MAA and supplementary applications.
Track record of interfacing effectively with FDA, EMA, and other global regulatory agencies.
Experience preparing marketing applications (NDA/BLA/MAA) in CTD format for major markets (U.S., EU, Canada).
Strong strategic skills, ability to make complex decisions, and willingness to defend difficult positions.
Excellent operational, planning, organizing, and motivation skills.
Exceptional verbal and written communication skills, comfortable presenting to all levels of an organization including senior management.
Strong interpersonal skills, maintaining composure, integrity, and credibility to build trust.
Ability to work collaboratively across a matrix organization and with cross‑functional teams.
Sense of urgency and perseverance to achieve results.
Salary and Benefits The base salary range for the Executive Director, Global Regulatory Affairs - Neurology is $272,200 - $357,300. The position is eligible to participate in Eisai Inc. Annual Incentive Plan & Eisai Inc. Long‑Term Incentive Plan. Employees are eligible to participate in company employee benefit programs. For additional information on company employee benefits programs, visit
https://us.eisai.com/careers-at-eisai/benefits .
Equal Opportunity Employer Eisai is an equal opportunity employer and is committed to recruiting, hiring, training, and promoting 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. Eisai prohibits discrimination against persons because of disability, including disabled veterans. Eisai participates in E‑Verify. For more information, please review the E‑Verify Participation notice.
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