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Codexis, Inc.

CMC Regulatory Director - FDA Advanced Manufacturing

Codexis, Inc., Redwood City, California, United States, 94061

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A leading biotechnology firm is seeking an Associate Director/Director of CMC Regulatory Affairs to guide regulatory activities for its ECO Synthesis platform. The role demands over 8 years of experience in CMC regulatory affairs, familiarity with regulatory submissions (INDs, DMFs), and strong leadership capabilities. Responsibilities include developing regulatory strategies, ensuring compliance with GMP standards, and liaising with the FDA. This position offers a competitive salary and a comprehensive benefits package including medical insurance, generous PTO, and onsite gym access. #J-18808-Ljbffr