Oncology Regulatory Project Manager

A company is looking for an Associate Director, Global Regulatory Project Management and Strategic Planning - Oncology.

Key Responsibilities

Partner with the Global Regulatory Lead to establish and maintain global regulatory project plans and ensure seamless execution of goals

Lead cross-functional project submission working groups to deliver successful submissions and outcomes with Health Authorities for various program phases

Provide regulatory operational support and oversight for assigned programs, ensuring compliance with timelines and company standards

Required Qualifications

Bachelor's degree required; emphasis in Science preferred, with an advanced degree preferred

Minimum of 8 years related experience, including 4 years in Global Regulatory Affairs

Experience with late-stage filings is highly preferred

Significant experience in global drug development regulations and regulatory submissions is required

Expertise with project management software and tools is essential