Global Regulatory Strategy Director

Eisai US; Nutley (NJ); Hybrid; 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

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.