Global Regulatory Affairs Director Neurology & Oncology

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

Benefits offered by this job

Hybrid work schedule

Job summary

Eisai seeks a Director, Global Regulatory Affairs in Nutley, NJ (hybrid three days a week) to drive regulatory strategy across neurology and oncology. Lead interactions with health authorities and coordinate cross-functional teams to secure approvals and lifecycle support.

The role requires extensive FDA experience, strategic oversight, and mentorship of regulatory teams, with a focus on timely, compliant submissions.

Qualifications

• Bachelor's degree in life sciences or related field; advanced degree preferred.
• Extensive regulatory/R&D experience in neurology/oncology sectors.
• Proven ability to translate strategy into actionable goals and budgets.
• Experience with major FDA submissions and global regulatory strategy.

Responsibilities

• Oversee regulatory submission activities and ensure quality and timelines.
• Lead drafting and submission of health authority documents and requests.
• Lead strategic regulatory discussions during submissions.
• Develop regulatory strategies across product lifecycles.
• Interpret scientific data and advise on regulatory implications.
• Monitor regulatory environment and communicate intelligence.
• Escalate regulatory concerns to senior leadership and teams.
• Coordinate interactions with health authorities for approvals.
• Manage and mentor the regulatory strategy team.

Skills

Communication & Cross-functional Influ

Critical Thinking & Agility

Mentoring/ People Development

Project Management

Regulatory Strategy Acumen

Education

Bachelor's degree

Master's preferred

Job description

Eisai seeks a Director, Global Regulatory Affairs in Nutley, NJ (hybrid three days a week) to drive regulatory strategy across neurology and oncology. Lead interactions with health authorities and coordinate cross-functional teams to secure approvals and lifecycle support.

The role requires extensive FDA experience, strategic oversight, and mentorship of regulatory teams, with a focus on timely, compliant submissions.