Director, Regulatory Affairs (Office based - 3x/week)

The Director, Regulatory Affairs is responsible for leading the development and execution of regulatory strategies for assigned assets, ensuring alignment and execution across regions. This role collaborates closely with other regulatory team members to prepare and manage submissions, leads interactions with health authorities, and ensures compliance with evolving regulatory requirements. Additionally, the Director serves as the US/EU regulatory lead, identifying and mitigating country-specific risks, supporting local submissions, and ensuring adherence to local regulations. The role involves representing Regulatory Affairs in cross-functional teams and governance forums.This position reports to the VP, Regulatory Affairs (US/EU) and is based in our South San Francisco, CA office.Global Regulatory Strategy: Lead the development and execution of regulatory strategies for assigned assets, ensuring alignment and coordination across regions.Regulatory Submissions: Oversee the planning, preparation, and management of regulatory submissions for assigned programs, ensuring quality and timely delivery.Health Authority Engagement: Serve as a primary point of contact with FDA and EMA, leading or supporting meetings and communications.  Ensures alignment of global Health Authority engagements with product strategy.Compliance: Ensure compliance with all applicable government regulations, industry guidelines, and internal policies for assigned programs.Regulatory Guidance: Interpret regulations, policies, and guidelines; advise cross-functional teams on regulatory requirements to support product development.Risk Management: Identify, assess, and proactively manage regulatory risks, developing and executing mitigation strategies.US/EU Regulatory expertise: Provide regulatory expertise for US and EU regions, identifying and mitigating country-specific risks, supporting local submissions, and ensuring adherence to local regulations.Cross-Functional Collaboration: Demonstrates a constructive and positive approach when working with colleagues. Encourages the exchange of information and the adoption of best practices. Represent Regulatory Affairs in cross-functional teams and governance forums, providing regulatory expertise throughout the product lifecycle.Regulatory Intelligence: Monitor and communicate changes in the regulatory environment and assess their impact on Zai Lab’s portfolio.Process Improvement: Contribute to the enhancement of regulatory processes and systems for greater efficiency and compliance.Maintains the highest standards of integrity and ethics. Contribute to building an open and trust atmosphere.  Ability to work across several time zones and travel up to 30%.