Oncology Regulatory Project Manager

Job Summary

To support innovative oncology therapies, the full-time remote Associate Director, Global Regulatory Project Management and Strategic Planning will manage regulatory project plans, lead cross-functional submission working groups, and ensure effective regulatory operational support for assigned programs.

Key responsibilities

• Partner with the Global Regulatory Lead to oversee and deliver on Global Regulatory Team goals and regulatory submissions
• Drive project teams to identify solutions and maintain focus on deliverables, while developing integrated regulatory project plans
• Prepare reports on regulatory milestone statuses and collaborate with stakeholders to present operational strategies and updates

Required qualifications

• Bachelor's degree required; emphasis in Science preferred, with an advanced degree preferred
• Minimum of 8 years of related experience, including 4 years in Global Regulatory Affairs
• Experience with late-stage filings and multiple eCTD registrations in the USA or other jurisdictions
• Demonstrated expertise in global drug development regulations and regulatory submissions
• Proven ability to lead cross-functional teams and manage multiple projects within assigned timelines