Christine Mao Wu
About Christine Mao Wu
Christine Mao Wu serves as the Executive Director of Global Regulatory Affairs at Nektar Therapeutics, where she has worked since 2019. With extensive experience in regulatory compliance and quality assurance, she has held various leadership roles in the biopharmaceutical industry, including positions at KYTHERA Biopharmaceuticals and Baxter Healthcare.
Work at Nektar Therapeutics
Christine Mao Wu currently serves as the Executive Director of Global Regulatory Affairs at Nektar Therapeutics, a position she has held since 2019. In this role, she oversees regulatory strategies and compliance for the company's product portfolio. Prior to her current role, she worked as Sr. Director of Regulatory Affairs at Nektar Therapeutics from 2017 to 2018. Her responsibilities include leading regulatory submissions and ensuring adherence to regulatory guidelines.
Previous Experience at KYTHERA Biopharmaceuticals
Christine Mao Wu worked at KYTHERA Biopharmaceuticals as the Director of Global Regulatory Affairs from 2014 to 2015. During her tenure, she facilitated meetings with the US FDA to address complex chemistry, manufacturing, and controls (CMC) and clinical issues, which contributed to a successful Biologics License Application (BLA) filing.
Regulatory Affairs at Baxter Healthcare
Christine Mao Wu held multiple positions at Baxter Healthcare. She served as Sr. Manager of Regulatory Compliance from 2002 to 2006 and later as Associate Director of Global Regulatory Affairs from 2006 to 2014. In these roles, she demonstrated leadership in regulatory compliance and contributed to the preparation and submission of regulatory documents across various regions.
Education and Expertise
Christine Mao Wu studied at Florida Atlantic University, where she earned a Master's degree in Organic Chemistry from 1992 to 1995. She also studied at Eastern China University of Chemical Technology. Her educational background supports her extensive experience in regulatory affairs, quality compliance, and process validation for biologics and small molecules.
Regulatory Strategy and Leadership Skills
Christine Mao Wu has demonstrated strong partnering and leadership skills in cross-functional team discussions, ensuring strategic implementation within regulatory submissions. She has led the preparation of regulatory documents in both ICH and non-ICH regions, including Asia Pacific and Latin America. Additionally, she has developed risk identification and mitigation plans as part of regulatory strategy execution.