Global Regulatory Strategy Director (Hybrid)

Eisai; Chicago (IL); Hybrid; USD 202,000 - 265,000; Full time

Job summary

Eisai is seeking a Director of Global Regulatory Affairs to lead submission strategies for neurology or oncology products, guiding regulatory plans from development through lifecycle and coordinating with health authorities.

The role emphasizes translating strategy into operational goals, managing cross-functional teams, and driving global regulatory programs to timely approvals. This hybrid position involves regular travel and collaboration with marketing and development teams.

Qualifications

• Bachelor's degree required; Master's preferred
• Extensive regulatory/R&D experience in neurology or oncology
• Experience translating strategy into operational goals and managing budgets/vendors
• Experience with major FDA submissions and global regulatory strategies
• Leadership experience in regulatory strategy teams is preferred

Responsibilities

• Oversee regulatory submission activities and review documents for quality and timelines
• Draft, compile and submit documents for health authorities (iPSPs/PSPs, orphan drug designation)
• Lead strategic regulatory discussions during drafting and submission activities
• Develop regulatory strategies throughout the product lifecycle
• Interpret scientific data to address regulatory requirements and strategy
• Monitor regulatory environment and provide intelligence on competitors
• Communicate regulatory issues across functions and to senior leadership
• Lead regulatory strategy teams and mentor staff

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 to lead submission strategies for neurology or oncology products, guiding regulatory plans from development through lifecycle and coordinating with health authorities.

The role emphasizes translating strategy into operational goals, managing cross-functional teams, and driving global regulatory programs to timely approvals. This hybrid position involves regular travel and collaboration with marketing and development teams.