Location: San Diego, CA (Hybrid)

A growing, innovation-driven biopharmaceutical organization is seeking an experienced Executive Director, Regulatory Strategy to provide strategic leadership across a diverse development portfolio. This individual will play a critical role in shaping global regulatory strategies from early development through commercialization, partnering closely with cross-functional stakeholders to advance programs that address significant unmet patient needs.

Key Responsibilities

• Lead the development and execution of global regulatory strategies across multiple development programs and lifecycle stages.
• Serve as a trusted regulatory advisor to senior leadership, providing strategic guidance on complex regulatory, clinical, safety, and business considerations.
• Drive cross-functional alignment with Clinical Development, Safety, CMC, Quality, Commercial, and Legal teams.
• Represent regulatory strategy in governance forums and influence key portfolio and development decisions.
• Guide regulatory interactions with global health authorities and support the preparation of major submissions and regulatory milestones.
• Lead, mentor, and develop a high-performing regulatory team while fostering a collaborative and accountable culture.
• Ensure compliance with evolving global regulatory requirements and industry best practices.

Ideal Background

• Extensive experience in regulatory affairs within the biotechnology, pharmaceutical, or life sciences industry.
• Proven success developing regulatory strategies across both development-stage and commercialized products.
• Strong understanding of FDA and global regulatory frameworks.
• Demonstrated ability to influence senior stakeholders and lead through complexity and ambiguity.
• Experience supporting complex therapeutic programs, including rare disease, specialty, or other highly regulated indications, is preferred.
• Outstanding communication, leadership, and relationship-building skills.
• Advanced scientific degree preferred.

Opportunity

This is an exciting opportunity to join a well-funded, growth-oriented organization committed to advancing innovative therapies for patients with serious diseases. The role offers significant visibility, strategic influence, and the ability to shape the regulatory direction of a meaningful pipeline while leading and developing a talented regulatory team.