Director, Global Regulatory Affairs

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 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.

About the role

Directs the development and submission of Neurology or Oncology product registration, progress reports, supplements, amendments, and/or periodic experience reports. Provides strategic product direction to teams on interaction and negotiates evidence with regulatory agencies. Serves as a regulatory liaison on the project team throughout the product lifecycle. Ensures that pre-clinical and clinical trials designs meet regulatory requirements and that new drugs, biologics/biotechnology, and/or medical devices receive rapid and timely approval, as well as continued approved status of marketed products.

Responsibilities

• Oversee regulatory submission activities and review regulatory documents (annual reports, protocol amendments) prior to submission to ensure overall quality, compliance, and timelines.
• Support or lead (depending on program complexity) the drafting, compilation, and submission of documents for health authorities (e.g., meeting requests/scientific advice requests, iPSPs/PSPs, orphan drug designation requests).
• As a Regional or Global Regulatory Lead, initiate and lead strategic regulatory discussions during the drafting, compilation, and submission of documents for health authorities (e.g., meeting requests/scientific advice requests, iPSPs/PSPs, orphan drug designation requests, protocol amendments).
• Identify regulatory requirements and develop successful regulatory strategies; lead the creation of regulatory strategy throughout the product lifecycle.
• Understand and interpret scientific data and complex scientific issues across multiple projects as they relate to regulatory requirements and strategy.
• Continuously evaluate the regulatory environment for impact on development programs; develop and communicate regulatory intelligence concerning competitor products.
• Communicate regulatory issues to functional areas and transmit regulatory concerns from functional areas to senior leadership.
• Lead interactions with health authorities to ensure timely preparation of scientifically valid submissions with the highest probability of success.
• Manage regulatory strategy team(s), including training, mentoring, communicating expectations, and evaluating performance.

Requirements

• Bachelor's degree (Master's preferred) and 10+ years of relevant experience. Experience in the Life Sciences industry preferred.
• Bachelor's or advanced degree in sciences or a related field with substantial experience in regulatory/R&D, specifically direct neurology or oncology regulatory experience in the pharma/biotech industry, or a combination of equivalent education and experience.
• Substantial experience translating strategy into operational goals, managing budget, vendors, and resource allocation, and communicating cross-functionally with the ability to influence without authority.
• Demonstrated experience with major FDA submissions and dealing with health authorities.
• Experience leading or developing global regulatory strategies in coordination with clinical plans and marketing objectives.
• Strong project management experience leading multiple critical projects and programs within regulatory strategy.
• Prior experience leading regulatory strategy teams directly in a supervisory/leadership capacity preferred.
• This position is hybrid in our Nutley, NJ office three days per week (Tuesday, Wednesday, Thursday). Remote candidates who are unable to regularly work in our Nutley, NJ office will be considered.
• Must be available for regular business travel (conferences, congresses, team meetings, audits, and inspections).

Skills

• Communication & Cross-functional Influence
• Critical Thinking & Business Agility
• Mentoring/People Development
• Project Management
• Regulatory Strategy Acumen

Pay

The annual base salary range for the Director, Global Regulatory Affairs is $201,800–$264,800. Under current guidelines, this position is eligible to participate in Eisai Inc. Annual Incentive Plan & Eisai Inc. Long Term Incentive Plan. Final pay determinations will depend on various factors including experience level, education, knowledge, and skills.

Benefits

Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit https://careers.eisai.com/us/en/compensation-and-benefits. Certain other benefits may be available for this position.

Schedule

This is a hybrid position based in Nutley, NJ, requiring three days per week in the office (Tuesday, Wednesday, Thursday).