Description

You will lead global regulatory submission planning and execution for oncology drug marketing applications, partnering with cross-functional teams to translate regulatory strategies into actionable plans and drive operational excellence.

Requirements

• Bachelor's degree in life sciences or related discipline; advanced degree preferred.
• 15+ years pharma/biotech industry experience, including 8-10 years regulatory project management.
• Hands-on U.S. drug marketing application experience required.
• Strong knowledge of global regulatory regulations, guidelines, and submission pathways.
• Exceptional project management skills with ability to manage multiple complex programs under compressed timelines.

Responsibilities

• Project manage regulatory submissions from initiation through submission, defining scope, timelines, and resources.
• Develop and track comprehensive submission timelines for INDs/CTAs, NDAs/MAAs, amendments, and agency interactions.
• Partner with Global and Regional Regulatory Science Leads to advance global regulatory strategies.
• Facilitate Global Regulatory Teams to ensure coordinated execution of high-quality regulatory deliverables.
• Drive operational planning and tracking of new drug marketing application submissions across cross-functional filing teams.