Senior Director of Regulatory Strategy

Job Summary

Providing strategic leadership for a therapeutic area portfolio, the full-time Senior Director of Regulatory Strategy will oversee global regulatory strategies, manage regulatory submissions, and engage with health authorities while working remotely.

Key Responsibilities

• Lead the development and execution of global regulatory strategies for a portfolio of products throughout their lifecycle
• Oversee major regulatory milestones and ensure timely submissions and approvals for INDs, NDAs, and other critical documents
• Establish and manage global health authority engagement strategies, serving as the senior regulatory advisor for significant interactions

Required Qualifications

• Advanced degree in a scientific discipline; PhD, PharmD, MD, or equivalent preferred
• Minimum 15 years of progressive regulatory affairs experience in the pharmaceutical or biotechnology industry
• Proven experience in developing and leading global regulatory strategies across multiple programs
• Demonstrated success in influencing portfolio-level decisions and achieving regulatory approvals in major global markets
• Strong understanding of portfolio governance and cross-functional drug development processes