Global Regulatory Strategy Director, Neurology/Oncology

Eisai; Nutley (NJ); Hybrid; USD 249,000 - 327,000; Full time

Job summary

Eisai in Nutley, NJ seeks a Senior Director, Global Regulatory Strategy, Neurology to identify and implement regulatory strategies for the global Neurology/Oncology portfolio and coordinate FDA, EMEA, and PMDA submissions. The role includes leading regulatory affairs activities, committee participation, and health authority interactions.

The position is hybrid in Nutley, NJ (three days/week) with eligibility for remote candidates, and requires regular travel to conferences, audits and meetings.

Qualifications

• Bachelor's degree (Master's preferred) and 12+ years of relevant experience.
• Experience in Life Sciences industry preferred.
• Bachelor's or advanced degree in sciences or related field with significant regulatory/R&D experience.
• OR a combination of equivalent education and experience.
• Proven experience in strategy development within area with cross-functional teams and budget planning.

Responsibilities

• Function as a Regional or Global Regulatory strategy lead and oversee regulatory submission activities and review documents for quality and timelines.
• Lead strategic regulatory discussions and drafting for health authorities and complex submissions.
• Identify, develop and implement regulatory strategies aligned with business plans.
• Lead regulatory activities with emphasis on strategy and preparation of documents for health authorities.
• Combine scientific, regulatory, and business knowledge to drive Eisai's regulatory strategies.
• Identify strategic opportunities and threats to optimize resources and risks.
• Direct budgeting, forecasting, vendor management, timelines, and resource needs for regulatory programs.
• Lead initiatives to improve regulatory strategy processes and systems with key stakeholders.
• Ensure deliverables are defined, information cascades, and accountability across teams.
• Direct people management including goal setting, performance review, development and engagement.

Skills

Communication & Cross-functional Influ

Critical Thinking & Business Agility

Mentoring/ People Development

Project Management

Regulatory Strategy Acumen

Education

Bachelor's degree

Master's degree preferred

Job description

Eisai in Nutley, NJ seeks a Senior Director, Global Regulatory Strategy, Neurology to identify and implement regulatory strategies for the global Neurology/Oncology portfolio and coordinate FDA, EMEA, and PMDA submissions. The role includes leading regulatory affairs activities, committee participation, and health authority interactions.

The position is hybrid in Nutley, NJ (three days/week) with eligibility for remote candidates, and requires regular travel to conferences, audits and meetings.