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 ResponsibilitiesLead 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 BackgroundExtensive 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.OpportunityThis 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.
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