Hybrid Global Regulatory Strategy Director

Eisai; Boston (MA); Hybrid; USD 202,000 - 265,000; Full time

Job summary

Eisai is seeking a Director of Global Regulatory Affairs in Nutley, NJ, hybrid role with regular travel. You will direct submissions, craft regulatory strategies, and liaise with health authorities to expedite approvals for neurology/oncology products.

Strong leadership and cross-functional collaboration are essential. Candidates should have 10+ years in regulatory/R&D in life sciences, with FDA interactions and a track record of coordinating global strategies across clinical, marketing, and

Qualifications

• Bachelor's degree with 10+ years in regulatory/R&D; neurology or oncology preferred.
• Experience translating strategy into operational goals, managing budgets, and coordinating with cross-functional teams.
• Demonstrated experience with major FDA submissions and interactions with health authorities.
• Experience leading global/regional regulatory strategies in alignment with clinical plans and marketing objectives.
• Proven ability to influence without direct authority and manage multiple programs.
• Willingness to travel regularly; hybrid Nutley, NJ role with some remote options.

Responsibilities

• Oversee regulatory submission activities and ensure quality, compliance, and timelines.
• Lead drafting, compilation and submission of documents for health authorities.
• Initiate and lead strategic regulatory discussions during submissions and interactions with authorities.
• Develop and communicate regulatory strategies across the product lifecycle.
• Interpret scientific data to address regulatory requirements and strategy.
• Monitor evolving regulatory environments and provide competitive intelligence.
• Communicate regulatory issues to cross-functional teams and leadership.
• Lead regulatory strategy teams, including training and performance evaluation.

Skills

Communication

Cross-functional Influence

Critical Thinking

Business Agility

Mentoring

People Development

Project Management

Regulatory Strategy

Education

Bachelor's degree (Master's preferred)

Advanced degree in sciences

Job description

Eisai is seeking a Director of Global Regulatory Affairs in Nutley, NJ, hybrid role with regular travel. You will direct submissions, craft regulatory strategies, and liaise with health authorities to expedite approvals for neurology/oncology products.

Strong leadership and cross-functional collaboration are essential. Candidates should have 10+ years in regulatory/R&D in life sciences, with FDA interactions and a track record of coordinating global strategies across clinical, marketing, and