Associate Director, Regulatory Affairs (Onsite in S.SF - 3X/wk)

Company Description

Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) is an innovative, research-based, commercial-stage biopharmaceutical company based in China and the United States focused on bringing transformative medicines for oncology, autoimmune disorders, infectious diseases, and neurological disorders to patients in China and around the world. Our goal is to leverage our competencies and resources to positively impact human health worldwide.

Founded in 2014, our experienced team has secured partnerships with leading global biopharmaceutical  companies, generating a broad and late-stage pipeline of innovative drug candidates. Based on our proven  track record of  success, Zai Lab has earned the reputation as a trusted partner of choice for global biopharmaceutical companies seeking to not only access the Chinese market but also find a long-term strategic partner for global clinical development.  Our unique business model builds on our in-licensed assets and innovative partnerships to expand our internal discovery and development capabilities and has created a portfolio of potential best-in-class and/or first-in-class therapies. Zai currently has four products on the market in China

Zai Lab was successfully listed on the Nasdaq Stock Market in September 2017 and completed secondary listing on Hong Kong Stock Exchange in September 2020. In 2022, Zai Lab became dual-primary listed on both the Nasdaq and the Hong Kong Stock Exchanges. Since its inception, Zai Lab has expanded significantly with several offices across China. In 2021, Zai Lab established its U.S. Headquarters in Cambridge, Massachusetts.  As of January 2022, the Company has a global team of approximately 2000 employees.

Job Description

Primary Function:

The Associate Director, Regulatory Affairs supports the development and execution of clinical regulatory strategies and regulatory development activities for assigned programs across regions. This role works closely with senior regulatory leadership to develop recommendations, execute regulatory plans, prepare submissions, and support health authority interactions. The Associate Director provides regulatory guidance to cross‑functional teams and ensures regulatory deliverables are completed in accordance with applicable regulations, timelines, and internal standards.

This position reports to the VP, Regulatory Affairs and is based in our South San Francisco, CA office.

Major Responsibilities and Duties:

• Regulatory Strategy Support: Support the development and execution of clinical regulatory strategies for assigned programs under the direction of senior regulatory leadership, including contributing analyses, options, and regulatory recommendations.
• Regulatory Submissions: Plan, prepare, and manage Investigational New Drug (IND) applications and other pre‑ or post‑IND regulatory submissions (e.g., amendments, briefing packages, and annual reports), ensuring accuracy, quality, and timely delivery. Manage regulatory timelines, deliverables, and commitments for assigned programs in coordination with cross‑functional teams and ensure submission content is prepared in accordance with applicable electronic submission standards and internal processes.
• Health Authority Interactions: Prepare health authority meeting materials, responses to information requests, and supporting documentation, and participate in interactions with health authorities as part of the regulatory team.
• Regulatory Guidance: Provide day‑to‑day clinical regulatory guidance to cross‑functional teams by interpreting regulations, policies, and guidance documents and applying them to program activities, including providing regulatory input into clinical development documents such as protocols, Investigator’s Brochures, and study reports to ensure alignment with regulatory expectations.
• Compliance: Execute regulatory activities in compliance with applicable global and regional regulations industry guidelines, and internal policies and procedures, maintaining inspection‑ready documentation and practices.
• Risk Identification: Proactively identify regulatory risks, issues, and gaps for assigned programs and develop mitigation approaches for discussion with regulatory leadership.
• Cross‑Functional Collaboration: Lead clinical regulatory execution for assigned programs on cross-functional teams, coordinating inputs from Clinical, Nonclinical, Biometrics, Medical Writing, CMC, and other functions. Partner with CMC Regulatory Affairs and technical subject matter experts to ensure alignment of development and submission activities while maintaining primary responsibility for clinical regulatory strategy and execution.
• Regulatory Intelligence: Monitor regulatory developments relevant to assigned programs and assess potential impacts, communicating findings to regulatory leadership and program teams.
• Process Improvement: