Hybrid/Remote Director, Global Regulatory Affairs

Eisai; Philadelphia (Philadelphia County); Hybrid; USD 202,000 - 265,000; Full time

Job summary

Eisai is seeking a Director, Global Regulatory Affairs in Nutley, NJ for a hybrid role three days per week. You will lead regulatory submissions, develop strategies across the product lifecycle, and coordinate with health authorities to obtain timely approvals.

The role requires a strong background in neurology/oncology regulatory affairs and experience leading cross-functional teams. Occasional travel and remote work considerations are expected.

Qualifications

• Bachelor's degree (Master's preferred) and 10+ years of relevant experience.
• Bachelor's or advanced degree in sciences or related field with regulatory experience.
• Experience translating strategy into operational goals and managing budgets.

Responsibilities

• Oversee regulatory submission activities and ensure quality and timelines.
• Lead drafting and submission of documents for health authorities.
• Coordinate strategic regulatory discussions during document submissions.
• Develop regulatory strategies across the product lifecycle.
• Interpret scientific data for regulatory requirements and strategy.
• Monitor regulatory environment and communicate intelligence.
• Communicate regulatory issues to cross-functional teams.
• Lead interactions with health authorities to ensure timely submissions.
• Manage regulatory strategy teams and mentor staff.

Job description

Eisai is seeking a Director, Global Regulatory Affairs in Nutley, NJ for a hybrid role three days per week. You will lead regulatory submissions, develop strategies across the product lifecycle, and coordinate with health authorities to obtain timely approvals.

The role requires a strong background in neurology/oncology regulatory affairs and experience leading cross-functional teams. Occasional travel and remote work considerations are expected.