Senior Global Regulatory Director, Neurology — Hybrid/Remote

Eisai US; Nutley (NJ); Ibrido; USD 249.000 - 327.000; Tempo pieno

Descrizione del lavoro

Eisai Inc. is seeking a Senior Director, Global Regulatory Affairs, Neurology, to lead regulatory strategy for the global neurology/oncology portfolio.

This role oversees submissions, milestones, and clinical strategies, engaging with health authorities and cross-functional teams in a fast-paced environment from Nutley, NJ with hybrid work options. The Senior Director will manage regulatory strategies, budgets, vendor relations, and cross-functional collaborations to meet business goals while

Competenze

• 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.
• Experience interfacing with FDA and international health authorities; knowledge of FDA laws and guidances.

Mansioni

• Function as a Regional or Global Regulatory strategy lead for regulatory submission activities.
• Lead strategic regulatory discussions and drafting documents for health authorities.
• Identify, develop and implement regulatory strategies for global portfolios.
• Lead regulatory activities with emphasis on strategy and document preparation for health authorities.
• Drive execution of Eisai's regulatory strategies through scientific, regulatory, and business insights.
• Identify strategic opportunities and threats; ensure resources to mitigate risks.
• Direct budgeting, vendor management, timelines, and resource planning for regulatory programs.
• Lead initiatives to improve regulatory strategy processes and systems with key stakeholders.
• Ensure clear deliverables, proper communication, and accountability within teams.
• Direct people management including goal setting, performance management, and development.

Conoscenze

Communication

Cross-functional Influence

Critical Thinking

Business Agility

Mentoring/People Development

Project Management

Regulatory Strategy Acumen

Formazione

Bachelor's degree (Master's preferred)

Descrizione del lavoro

Eisai Inc. is seeking a Senior Director, Global Regulatory Affairs, Neurology, to lead regulatory strategy for the global neurology/oncology portfolio.

This role oversees submissions, milestones, and clinical strategies, engaging with health authorities and cross-functional teams in a fast-paced environment from Nutley, NJ with hybrid work options. The Senior Director will manage regulatory strategies, budgets, vendor relations, and cross-functional collaborations to meet business goals while