Sr Director, Regulatory Affairs Strategy

Role Summary

• Provide strategic and tactical regulatory leadership across product development, filing, and lifecycle management to ensure timely US and international approvals and compliant post-market performance.

• Lead cross-functionally by collaborating across organizational levels and influencing cross-functional decision-making to drive regulatory success.
• Oversee development and execution of global regulatory strategies from early development through post-approval for complex assets/indications.
• Lead global regulatory strategy and manage major US/global regulatory submissions, rollout, and lifecycle management for marketed products including post-approval changes to maintain continuous compliance.
• Represent regulatory affairs in governance and interactions with global health authorities as applicable.
• Own US regulatory submissions and approvals for assigned projects.
• Identify and communicate regulatory hurdles, risks, opportunities, and innovative pathways to accelerate development and approval.
• Develop regulatory intelligence gathering and regulatory influence management at the portfolio level.
• Provide leadership and development to other regulatory strategists to ensure fit-for-phase strategies from FIH to approval.
• Lead regulatory strategy for business development and due diligence (assessment, risk identification/mitigation, precedent leverage, regulatory probability of success).
• Establish best practices across Regulatory Affairs and other R&D functions; lead development of regulatory policies/procedures; ensure regulatory record keeping.
• Participate in and lead professional associations/industry groups as appropriate for assigned projects.

• 15+ years of regulatory affairs experience (US and ex-US).
• MS, Ph.D., or PharmD in a scientific discipline.

• Strong written and verbal communication.
• Critical thinking, leadership, assertiveness, negotiation, and project management skills.
• Deep understanding of US FDA and international pharmaceutical guidance/regulations and drug development.
• Ability to prioritize, coordinate, and thrive in a fast-paced environment.
• Strong decision-making, collaboration/team-building, outcome orientation, business acumen, and innovative mindset.

• Up to 20%.

• Expected base pay range: $,100 plus bonus, stock equity, and comprehensive benefits (health, dental, vision) and generous paid time off.

• Irvine office (hybrid; remote work may be considered).