Senior Director, Regulatory CMC

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.

Responsible for leading the global CMC regulatory strategy and execution for both small molecule and biological projects across all phases of development, including strategy, dossier preparation and submissions, and responses to the regulatory agencies’ requests.

• Lead the preparation of global CMC regulatory submissions for both small molecules and biologics, including IND/
  CTA
  , NDA/BLA/
  MAA applications. Oversee the end-to-end CMC dossier preparation, review, and finalization, ensuring scientific soundness, data integrity, and regulatory compliance across all product modalities.
• Develop and implement comprehensive regulatory CMC strategies to facilitate the progress of programs in all phases of development, with focus on late-stage development and post-approval regulatory support for all GMP-related activities (change control, deviation regulatory evaluation, etc.).
• Act as the primary CMC contact for interactions with health authorities (e.g., NMPA, CDE, FDA, EMA) on CMC-related issues, including leading pre-IND/NDA/BLA meetings and responses to regulatory questions.
• Lead regulatory risk assessment, identify key CMC issues, and define mitigation activities throughout the product lifecycle.
• Provide strategic regulatory CMC guidance to cross-functional project teams to ensure development activities comply with relevant guidelines and governmental regulations.
• Ensure that the content and format of regulatory submissions comply with applicable regulations and guidelines (ICH, NMPA, FDA, EMA, etc.).
• Lead and manage a team of CMC regulatory professionals, including mentoring, performance management, and career development.
• Contribute to the development of internal regulatory CMC guidance, working instructions, and process improvements to enhance dossier quality and review efficiency.
• Maintain up-to-date knowledge of evolving regulatory requirements, guidelines, and technical trends in both small molecule and biologics CMC domains.
• Collaborate effectively with internal stakeholders (e.g., QA/QC, R&D, manufacturing) and external partners to deliver high-quality dossiers and support business priorities.

• PHD in scientific discipline with eight years of regulatory experience; or equivalent combination of education, training and experience. RAC certification is a plus.
• Excellent verbal and written communication skills in both English and Chinese, with the ability to…