Global Regulatory Affairs Lead — Hybrid & Strategic

Eisai US; Nutley (NJ); Hybrid; USD 165,000 - 217,000; Full time

Job summary

Eisai US in Nutley, NJ seeks an Associate Director, Global Regulatory Affairs to provide comprehensive regulatory support for supplemental indications and lead early phase regulatory work for neurology or oncology candidates.

Responsibilities include leading submissions, strategizing global development approvals, and coordinating with cross-functional teams to optimize timelines and compliance.

Qualifications

• Bachelor's or advanced degree in sciences or related field.
• 6+ years of experience in regulatory/R&D with strong experience in new drug regulated product strategy/submissions in pharma/biotech industry.
• Or a combination of equivalent education and experience.
• Experience mentoring and training team members on submission/regulatory strategy activities.
• Experience developing global regulatory strategies in coordination with clinical plans and marketing objectives.
• Proven experience leading multiple/ large/complex project(s), tracking and managing regulatory strategy budgets, resources and regulatory filings.
• Experience engaging with critical cross-functional stakeholders to drive processes/systems and outcomes.
• Proven performance in earlier role.

Responsibilities

• Lead drafting and compilation of submissions to health authorities.
• Lead generation of reports, tracking submissions/approvals and documentation.
• Serve as Regional or Global Regulatory Lead; develop regulatory strategies for global approval of new medicinal products.
• Act as contact interfacing with regulatory authorities for assigned product(s).
• Develop regulatory strategy for assigned markets and support registration/post-licensing activities.
• Lead planning and assessment of product life cycle management activities.
• Partner with project teams to align regulatory resources and support needs.
• Develop contingency plans for regulatory objectives and risk mitigation.

Skills

Communication & Cross-functional Influ

Critical Thinking & Agility

Mentoring/ People Development

Project Management

Regulatory Strategy Acumen

Education

Bachelor's or advanced degree in sciences or related field

Equivalent education and experience

Job description

Eisai US in Nutley, NJ seeks an Associate Director, Global Regulatory Affairs to provide comprehensive regulatory support for supplemental indications and lead early phase regulatory work for neurology or oncology candidates.

Responsibilities include leading submissions, strategizing global development approvals, and coordinating with cross-functional teams to optimize timelines and compliance.