Global Regulatory Strategy Director (Hybrid)

Eisai; Middle River (MD); Hybrid; USD 202,000 - 265,000; Full time

Job summary

Eisai is seeking a Director, Global Regulatory Affairs in Nutley, NJ, a hybrid role requiring regular office presence three days a week with some remote options. You will direct submissions, negotiate with health authorities, and shape global regulatory strategies across neurology/oncology products.

The position requires a senior-level background with 10+ years in regulatory/R&D, strong leadership, and cross-functional influence to drive approvals and lifecycle management.

Qualifications

• Bachelor's degree in Life Sciences or related field; Master’s preferred.
• 10+ years of regulatory experience in life sciences/pharma/biotech.
• Experience leading regulatory strategy across product lifecycle and interactions with health authorities.
• Global/regional regulatory strategy leadership experience.
• Strong cross-functional and vendor management skills.

Responsibilities

• Oversee regulatory submission activities ensuring quality, compliance and timelines.
• Lead drafting and submission of documents for health authorities (meetings, PSPs, orphan drug designation).
• Initiate and lead strategic regulatory discussions during document drafting and submissions.
• Develop and implement regulatory strategies across product lifecycle.
• Interpret scientific data and regulatory requirements across multiple projects.

Skills

Communication & Cross-functional Influ

Critical Thinking & Business Agility

Mentoring/ People Development

Project Management

Regulatory Strategy Acumen

Education

Bachelor's degree (Master's preferred)

Advanced degree in sciences or related field

Job description

Eisai is seeking a Director, Global Regulatory Affairs in Nutley, NJ, a hybrid role requiring regular office presence three days a week with some remote options. You will direct submissions, negotiate with health authorities, and shape global regulatory strategies across neurology/oncology products.

The position requires a senior-level background with 10+ years in regulatory/R&D, strong leadership, and cross-functional influence to drive approvals and lifecycle management.