Global Regulatory Lead

Job Summary

To support the rapid growth of its early-stage pipeline, the full-time Early Development Global Regulatory Lead will provide strategic regulatory leadership for early development programs, ensuring alignment across cross-functional teams and facilitating timely regulatory guidance in a remote setting.

Key responsibilities

• Provide global regulatory leadership for assigned early development programs, ensuring clear regulatory strategy and risk identification
• Co-create and implement innovative global regulatory strategies to expedite development milestones through the end of first-in-human studies
• Mentor and coach members of the Early Development regulatory team while building relationships with internal stakeholders

Required qualifications

• Minimum 15 years of regulatory affairs experience within biopharmaceutical organizations, including 5-7 years in global leadership roles
• Advanced scientific degree preferred, such as PhD or PharmD
• Strong understanding of drug development with direct experience in early clinical development and regulatory strategy for innovative medicines
• Proven ability to develop global regulatory strategies that support early asset progression and regulatory interactions
• Experience interacting with regulatory authorities on scientific advice and IND/CTA activities