Global Regulatory Lead

Job Summary

A company is looking for an Early Development Global Regulatory Lead.

Key Responsibilities

• Act as a key member of the Early Development regulatory team and contribute to developing regulatory strategies
• Co-create and implement innovative global regulatory strategies to expedite development milestones
• Oversee regulatory affairs vendors and ensure high-quality interactions with regulators

Required Qualifications

• Minimum 15 years of regulatory affairs experience in biopharmaceutical organizations, with 5-7 years in global leadership roles
• PhD or PharmD preferred
• Thorough understanding of the drug development process and expertise in orphan drugs
• Experience interacting with regulatory authorities, especially the FDA and EMA
• Proven ability to build, motivate, and develop a team