Mace Mamlok
Associate Director Regulatory Affairs @Sutro Biopharma, Inc.
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WORK HISTORY
Associate Director Regulatory Affairs @Sutro Biopharma, Inc.
Lead global Regulatory CMC strategy and lifecycle management for Sutro’s clinical pipeline, including the preparation and oversight of IND, IMPD, BLA, and DMF submissions. Coordinate cross-functional efforts between Manufacturing, Analytical, and Quality teams to ensure CMC packages meet global health authority requirements and ICH guidelines. Manage technical content and strategy for agency interactions, briefing books, and responses to information requests across both internal and partnered programs.
EDUCATION
Berkeley Extension
Certificate, Project Management
University of California, Davis
BS, Chemistry
SKILLS
ABOUT MACE MAMLOK
Associate Director of Regulatory Affairs with over 20 years of biotech experience spanning manufacturing, analytical development, and quality control. After a focus on the science behind the data, including serving as the analytical lead for the first FDA-approved peanut allergy treatment, I made the pivot to Regulatory CMC strategy. I bridge the gap between technical experts and global health authorities to ensure successful filing outcomes into clear, compliant narratives for IND, IMPD, and BLA submissions.
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