Global Regulatory Director - Hybrid (Neurology/Oncology)

Eisai; Woodcliff Lake (NJ); Hybrid; USD 202,000 - 265,000; Full time

Job summary

Eisai is seeking a Director, Global Regulatory Affairs in Nutley, NJ, to lead regulatory submissions, strategy, and cross-functional collaboration across neurology and oncology programs. This hybrid role emphasizes strong leadership and global regulatory execution to accelerate approvals and maintain high compliance.

The position targets experienced regulatory professionals with deep knowledge of FDA processes, clinical development strategy, and effective stakeholder management.

Qualifications

• Bachelor's degree in science required; master's preferred.
• 10+ years in regulatory/R&D with neurology or oncology regulatory experience in pharma/biotech.
• Experience translating strategy into operational goals and managing budgets.

Responsibilities

• Oversee regulatory submission activities and review regulatory documents prior to submission.
• Lead drafting and submission of documents for health authorities.
• Initiate strategic regulatory discussions during submissions.
• Identify regulatory requirements and develop regulatory strategies.
• Interpret scientific data and regulatory requirements across projects.
• Monitor regulatory environment and communicate regulatory intelligence.
• Communicate regulatory issues to senior leadership.
• Lead regulatory strategy teams and mentor staff.

Skills

Communication

Cross-functional Influence

Critical Thinking

Project Management

Regulatory Strategy

Education

Bachelor's degree (Master's preferred)

Advanced degree in sciences

Job description

Eisai is seeking a Director, Global Regulatory Affairs in Nutley, NJ, to lead regulatory submissions, strategy, and cross-functional collaboration across neurology and oncology programs. This hybrid role emphasizes strong leadership and global regulatory execution to accelerate approvals and maintain high compliance.

The position targets experienced regulatory professionals with deep knowledge of FDA processes, clinical development strategy, and effective stakeholder management.