Mirrai Careers

Associate Director / Director, Regulatory Affairs - CMC

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San Diego HQ Full-time$164k–$245k / year Posted 30+ days ago
JOB SUMMARY The Associate Director/Director of Regulatory Affairs - Chemistry, Manufacturing and Controls (CMC) will lead global CMC regulatory strategy and execution across the company's development programs. The role will prepare and oversee high-quality CMC content for regulatory submissions, provide phase-appropriate regulatory guidance, identify and mitigate risks, and ensure alignment with program objectives and global requirements. This individual will partner closely with Technical Operations, Process Chemistry, Analytical Development, Formulation, Manufacturing, Quality, Clinical,…

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