Senior Director, Global Regulatory Strategy, Neurology

Eisai•Nutley, NJ

1d•$249,100 - $327,000•Hybrid

About The Position

The Senior Director, Global Regulatory Strategy, Neurology identifies and implements company regulatory strategies for the global Neurology or Oncology portfolio and establishes standards aligned with short- and long-term business plans. Using a hands-on approach, the role ensures completion of goals and objectives related to regulatory submissions and milestones, clinical strategies, and trials. The position leads Regulatory Affairs activities, emphasizing regulatory strategy and the preparation, review, and evaluation of documents for FDA, EMEA, and PMDA submissions. It participates in internal and external committees, health authority interactions, and organizational decision-making processes as appropriate. The role also directs program financial planning and forecasting, budget and vendor management, timeline tracking, resource assessment, process improvements, and direct people management. The position is hybrid in Nutley, New Jersey, three days per week (Tuesday, Wednesday, and Thursday). Remote candidates who cannot regularly work from the Nutley office will also be considered. Regular business travel is required for conferences, congresses, team meetings, audits, and inspections. The annual base salary range is $249,100–$327,000. The position is eligible for Eisai Inc.’s Annual Incentive Plan and Long Term Incentive Plan, and employees may participate in company benefit programs.

Requirements

Bachelor’s degree and 12 or more years of relevant experience; a master’s degree is preferred.
A degree in sciences or a related field, with significant regulatory or R&D experience in drug development and regulatory work in the pharmaceutical or biotechnology industry, or equivalent education and experience.
Proven experience developing strategy, managing regulatory strategy processes through cross-functional teams, and planning and managing budgets.
Track record of effective interaction with the FDA and some experience with other health authorities.
Extensive experience with FDA laws, regulations, and guidance, as well as international regulations.
Ability to travel regularly for business.
Business-need-driven role, based on proven performance in an earlier role.

Nice To Haves

Experience in the life sciences industry.
Demonstrated working knowledge of clinical trial design and processes, including clinical data collection and analysis and preparation of regulatory submissions.
Significant project management experience leading multiple critical, complex regulatory strategy projects and programs.
Experience with major submissions, including NDA, BLA, MAA, or J-NDA.
Experience managing large regulatory strategy teams directly or indirectly in a leadership capacity.
Master’s degree.

Responsibilities

Function as a regional or global regulatory strategy lead; oversee submission activities and review regulatory documents, such as annual reports and protocol amendments, for quality, compliance, and timeliness.
Lead strategic regulatory discussions and draft documents for health authorities, including meeting or scientific advice requests and other complex regulatory submission documents.
Identify, develop, and implement regulatory strategies and standards for the assigned global portfolio, aligned with short- and long-term business plans.
Lead regulatory activities, including regulatory strategy and the preparation, review, and evaluation of health authority documents.
Apply scientific, regulatory, and business-process knowledge to drive execution of regulatory strategies.
Identify strategic regulatory opportunities and threats, and ensure resources are available to mitigate risks and maximize success.
Direct financial planning and forecasting, budget management, vendor management, timeline development and tracking, and resource-needs assessment for assigned programs.
Lead initiatives to improve regulatory strategy processes and systems with key stakeholders.
Ensure team deliverables are clearly defined, important information is communicated throughout the organization, and accountability is maintained.
Directly manage employees, including goal setting, performance management, development, and engagement.
Participate in committees, health authority interactions, and organizational decision-making processes as appropriate.
Travel regularly for conferences, congresses, team meetings, audits, and inspections.