Global Regulatory Strategy Director (Hybrid)

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

Benefits offered by this job

Annual Incentive Plan

Long Term Incentive Plan

Company benefits

Job summary

Eisai is seeking a Director, Global Regulatory Affairs in Nutley, NJ, hybrid three days per week. You will oversee regulatory submission activities, provide strategic direction to teams, and lead interactions with health authorities to expedite approvals for neurology or oncology products.

This role requires a bachelor's degree with 10+ years in life sciences, experience with major FDA submissions, and the ability to translate strategy into operational goals while mentoring a regulatory strategy

Qualifications

• Bachelor's degree with 10+ years in regulatory/R&D
• Experience translating strategy into operational goals
• Major FDA submissions experience
• Global regulatory strategy leadership experience

Responsibilities

• Oversee regulatory submission activities and review documents for quality and timelines
• Lead drafting and submission of health authority documents (meetings, iPSPs/PSPs)
• Lead strategic regulatory discussions and development of regulatory strategy across product lifecycle
• Mentor and manage regulatory strategy teams and cross-functional partners

Skills

Regulatory Strategy Acumen

Communication

Cross-functional Influence

Mentoring/People Development

Project Management

Education

Bachelor's degree or higher

Master's preferred

Job description

Eisai is seeking a Director, Global Regulatory Affairs in Nutley, NJ, hybrid three days per week. You will oversee regulatory submission activities, provide strategic direction to teams, and lead interactions with health authorities to expedite approvals for neurology or oncology products.

This role requires a bachelor's degree with 10+ years in life sciences, experience with major FDA submissions, and the ability to translate strategy into operational goals while mentoring a regulatory strategy