Global Regulatory Affairs Director (Hybrid/Remote)

Eisai; Raleigh (NC); Hybrid; USD 202,000 - 265,000; Full time

Job summary

Eisai is seeking a Director, Global Regulatory Affairs to lead submission strategies for neurology and oncology products. You will guide teams through regulatory interactions, provide strategic direction, and ensure compliance across the product lifecycle.

The role is hybrid in Nutley, NJ (three days/week) with options for remote candidates and regular travel. Base salary is disclosed with incentive plans; compensation reflects experience and skills.

Qualifications

• Bachelor's degree (Master's preferred) and 10+ years of relevant experience.
• Degree in sciences with substantial regulatory/R&D experience in neurology or oncology pharma/biotech.
• Strong ability to influence cross-functionally and manage budgets/vendors.
• Experience with major FDA submissions and global regulatory strategies.
• Willingness to travel; hybrid Nutley, NJ; remote candidates considered.

Responsibilities

• Oversee regulatory submission activities and review regulatory documents for quality, compliance and timelines.
• Draft, compile and submit documents for health authorities (e.g., meetings, PSPs, orphan designation).
• Lead strategic regulatory discussions during drafting, compilation and submission to health authorities.
• Identify regulatory requirements and develop regulatory strategies across product lifecycle.
• Interpret scientific data and regulatory requirements; provide regulatory intelligence.
• Communicate regulatory issues to functional areas and senior leadership.
• Lead interactions with health authorities to ensure timely, scientifically valid submissions.
• Manage regulatory strategy teams, including training and performance evaluation.

Skills

Communication & Cross-functional Influ

Critical Thinking & Business Agility

Mentoring/ People Development

Project Management

Regulatory Strategy Acumen

Education

Bachelor's degree (Master's preferred)

Regulatory/R&D experience in neurology/oncology

Job description

Eisai is seeking a Director, Global Regulatory Affairs to lead submission strategies for neurology and oncology products. You will guide teams through regulatory interactions, provide strategic direction, and ensure compliance across the product lifecycle.

The role is hybrid in Nutley, NJ (three days/week) with options for remote candidates and regular travel. Base salary is disclosed with incentive plans; compensation reflects experience and skills.