Director, Global Regulatory Affairs

Eisai US; Nutley (NJ); On-site; USD 202,000 - 265,000; Full time

Benefits offered by this job

Annual Incentive Plan

Long Term Incentive Plan

Company benefits

Other benefits

Job summary

Eisai Inc. in Nutley, NJ is seeking a seasoned leader to direct regulatory submission activities for neurology/oncology products. You will provide strategic direction, negotiate with regulatory agencies, and serve as regulatory liaison across the project lifecycle to ensure rapid, compliant approvals.

The role requires 10+ years in regulatory/R&D, with strong FDA submission experience and ability to influence cross-functionally, guiding teams through evolving regulatory landscapes.

Qualifications

• Bachelor's degree (Master's preferred) with 10+ years in regulatory/R&D, preferably neurology or oncology.
• Strong translation of strategy into operational goals and cross-functional communication.
• Experience with major FDA submissions and global regulatory strategies.

Responsibilities

• Oversee/regulatory submission activities and ensure quality, compliance and timelines.
• Lead drafting and submission of documents for health authorities (FDA, etc.).
• Lead strategic regulatory discussions during document preparation and approvals.
• Develop regulatory strategies throughout the product lifecycle.
• Interpret scientific data to inform regulatory requirements and strategy.
• Monitor regulatory environment and communicate intelligence to leadership.
• Coordinate with health authorities to ensure timely, valid submissions.
• Manage regulatory strategy teams including training and mentoring.

Skills

Communication

Cross-functional Influence

Critical Thinking

Business Agility

Mentoring

People Development

Project Management

Regulatory Strategy

Education

Bachelor's degree or higher in sciences

Master's preferred

Job description

Company Overview

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.

Role Overview

Directs the development of 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. Interacts and negotiates with regulatory agency personnel in order to expedite approval of pending registration and answers any questions. Serves as a regulatory liaison on the project team throughout the product lifecycle. Ensures that pre-clinical and clinical trials designs meet regulatory requirements. Ensures rapid and timely approval on of new drugs, biologics/biotechnology and/or medical devices and continued approved status of marketed drugs or medical devices. Serves as regulatory representative to marketing or research project teams and government regulatory agencies. Provides advice to development and/or marketing teams on manufacturing changes, line extensions, technical labeling, appropriate regulations and interpretations. Supports collaboration development with partners by developing and communicating strategies and aligning on such strategies in advance of execution.

Responsibilities

• Oversee regulatory submission activities and review regulatory documents (annual reports, protocol amendments) prior to submission to ensure overall quality, compliance and timelines.
• Support/ 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 discussion 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).
• Responsible for identifying regulatory requirements and the development and preparation of 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 it relates to regulatory requirements and strategy.
• Continuously evaluate the constantly changing 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 the timely preparation of scientifically valid submission with highest probability of success.
• Manage regulatory strategy team(s) including training and mentoring, communicating expectations and evaluating performance.

Qualifications

• Bachelor's degree (Master's preferred) and 10+ years of relevant experience. Experience in Life Sciences industry preferred.
• Bachelor's or advanced degree in sciences or related field with substantial experience in regulatory/R&D area with direct neurology or oncology regulatory experience in pharma/biotech industry. OR a combination of equivalent education and experience.
• Substantial experience translating strategy into operational goals, managing budget, vendors & resource allocation and communicating cross functionally with an ability to influence without authority.
• Demonstrated experience with major FDA submissions, dealing with health authorities, preferred.
• Experience leading/developing global regulatory strategies in coordination with clinical plans and marketing objectives.
• Demonstrated 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.
• Business need driven role, based on proven performance in earlier role.

Location & Work Arrangement

This position is hybrid in our Nutley, NJ three days per week (Tuesday, Wednesday, Thursday). We will consider remote candidates who are unable to regularly work in our Nutley, NJ office. Must be available for regular business travel (conferences, congresses, team meetings, audits and inspections). Bachelor's degree (Master's preferred) and 10+ years of relevant experience. Experience in Life Sciences industry preferred.

Skills

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

Salary Transparency

Eisai Salary Transparency Language: The annual base salary range for the Director, Global Regulatory Affairs is from :$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 but not limited to experience level, education, knowledge, and skills. 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, please discuss any questions with your recruiter.

Benefits

• Annual Incentive Plan
• Long Term Incentive Plan
• Company employee benefit programs
• Other benefits available for this position

Equal Opportunity & Diversity Statement

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.

Employment Eligibility & E-Verify

Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information: Right To Work E-Verify Participation 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.

Additional Company Information

Eisai Inc. 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 and follow us on Twitter and LinkedIn. All data that is entered should be in the correct case, please refrain from using all caps. For a better user experience, we recommend using the latest version of Chrome.