Kristine Ha

Kristine Ha has over 16 years of experience in regulatory operations and management. Kristine is currently working at Eidos Therapeutics as the Senior Director, Regulatory Operations. Prior to this, they held the position of Director, Regulatory Operations at Eidos Therapeutics as well.

Before joining Eidos Therapeutics, Ha worked at Dermira, Inc. as the Director, Regulatory Operations. In this role, they served as the Head of Regulatory Operations and was responsible for leading electronic publishing efforts in support of INDs and NDAs submissions to FDA and other regulatory agencies.

Ha also has experience at BeiGene, where they held the role of Associate Director, Submissions Operations Management. In this position, they managed the Submissions Operations Management function, which included ex-APAC Submission Publishing, Global Technical Editing, and Global Regulatory Archiving. Kristine was accountable for ensuring publishing, editing, archiving, and general submission support and services, as well as staff training and development.

Earlier in their career, Ha worked at Esperion - The Lipid Management Company as the Associate Director, Global Regulatory Operations. In this role, they were responsible for regulatory operations publishing, submission management, regulatory information systems ownership, and dossier management for global marketing applications.

Ha began their career at Amgen, where they held various roles in regulatory operations, including Senior Manager, Manager, Senior Associate, and Associate. Kristine also worked briefly at One World Health as a Documentation Specialist and at Keryx Biopharmaceuticals as a Regulatory Associate.

Overall, Ha has a strong background in regulatory operations, including publishing, submission management, and dossier management. Kristine has experience in leading teams, managing vendors, and collaborating with cross-functional stakeholders to ensure timely and high-quality submission deliverables.

Kristine Ha completed their Bachelor of Science degree in Microbiology and Molecular Genetics as well as English Literature from UCLA between 1994 and 1999. Kristine then pursued further studies at the University of California, Berkeley from 2000 to 2006, focusing on English Literature. The information provided does not specify if they obtained a degree at Berkeley.