Global Regulatory Lead

Job Summary

Taking full ownership of global regulatory strategy for critical oncology assets, the contract-based Global Regulatory Lead will direct FDA and EMA agency interactions and manage regulatory submissions to bring life-changing cancer treatments to market, all while working remotely.

Key responsibilities

• Represent Regulatory Affairs in Global Project Team(s) and lead the regulatory sub-team (GRST) for assigned projects
• Drive the regulatory submission process and ensure high-quality preparation of all regulatory documentation
• Develop optimal regulatory strategies aligned with development plans and manage major regulatory agency interactions

Required qualifications

• Advanced degree with at least 6 years of relevant experience
• A minimum of 3 years of recent oncology experience
• Proven strategist with a record of successful interactions with FDA or EMA
• Demonstrated strong matrix leadership skills
• Excellent spoken and written English proficiency