Senior Global Regulatory Strategy Director, Neurology

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

Job summary

Eisai seeks a Senior Director, Global Regulatory Affairs, Neurology in Nutley, NJ. You will lead regulatory strategy for global Neurology/Oncology portfolios, oversee submissions to FDA, EMA, and PMDA, and guide cross-functional teams to align with business plans.

The role emphasizes regulatory strategy, document review, and interaction with health authorities, with a hybrid work arrangement three days per week and travel as needed.

Qualifications

• Bachelor's degree in sciences or related field with regulatory/R&D experience in pharma/biotech.
• Significant experience in regulatory strategy and cross-functional team management.
• Experience preparing NDA/MAA/J-NDA submissions and interacting with health authorities.

Responsibilities

• Lead regulatory strategy for global Neurology/Oncology portfolio and submissions.
• Draft, review and evaluate documents for FDA, EMA, and PMDA submissions.
• Direct regulatory strategy programs and budget planning with cross-functional teams.
• Identify opportunities/threats and ensure resource allocation and timelines.

Skills

Regulatory strategy

Cross-functional leadership

Project management

Clinical regulatory

FDA interactions

Education

Bachelor's degree

Master's preferred

Job description

Eisai seeks a Senior Director, Global Regulatory Affairs, Neurology in Nutley, NJ. You will lead regulatory strategy for global Neurology/Oncology portfolios, oversee submissions to FDA, EMA, and PMDA, and guide cross-functional teams to align with business plans.

The role emphasizes regulatory strategy, document review, and interaction with health authorities, with a hybrid work arrangement three days per week and travel as needed.