Global Regulatory Strategy Director

Eisai; Miami (FL); Hybrid; USD 202,000 - 265,000; Full time

Job summary

Eisai seeks a Director, Global Regulatory Affairs to drive regulatory submissions for Neurology and Oncology products, providing strategic direction and regulatory liaison across the product lifecycle.

The role involves leading global regulatory strategies, mentoring teams, and ensuring timely approvals through collaboration with clinical, marketing, and manufacturing functions. The position is hybrid in the US with regular travel.

Qualifications

• Bachelor's degree and 10+ years in Life Sciences with regulatory/R&D neurology or oncology experience.
• Combination of education and experience accepted.
• Experience translating strategy into operational goals, managing budget, vendors and cross-functional influence.
• Experience with major FDA submissions and global regulatory strategies.

Responsibilities

• Oversee regulatory submission activities to ensure quality, compliance and timelines.
• Lead drafting and submission of documents for health authorities (iPSPs/PSPs, orphan drug designation requests).
• Initiate and lead strategic regulatory discussions during document submission processes.
• Identify regulatory requirements and develop successful regulatory strategies throughout the product lifecycle.
• Interpret scientific data across projects for regulatory relevance and strategy.
• Monitor regulatory environment and communicate intelligence to leadership.
• Lead interactions with health authorities to enable timely, scientifically valid submissions.

Skills

Communication & Cross-functional Influ

Critical Thinking & Business Agility

Mentoring/ People Development

Project Management

Regulatory Strategy Acumen

Education

Bachelor's degree (Master's preferred)

Advanced degree in sciences or related field

Job description

Eisai seeks a Director, Global Regulatory Affairs to drive regulatory submissions for Neurology and Oncology products, providing strategic direction and regulatory liaison across the product lifecycle.

The role involves leading global regulatory strategies, mentoring teams, and ensuring timely approvals through collaboration with clinical, marketing, and manufacturing functions. The position is hybrid in the US with regular travel.