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Regulatory Affairs CMC Officer
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$120,000 - $150,000 a year
Full-time
- Forming part of the Biotechnology segment at Danaher, we bring together dedicated technical expertise and talent to develop the next generation of life-changing therapeutics.
- The Regulatory Affairs CMC Officer for Cytiva is responsible for leading CMC strategies for internal and partner programs.
- Lead development and execution of regulatory Chemistry, Manufacturing, and Controls (CMC) biomanufacturing strategies for internal and partner programs of all development phases, including varied programs in gene and cell therapy (CGT), antibody bioprocessing (mAb/biAb), mRNA products, and complex biologics.
- Proactively identifies CMC/cGMP issues and implements appropriate regulatory strategies to mitigate CMC dossier, QP, import/export, and other biomanufacturing regulatory documentation risks.
- Acts as subject matter expert and maintains current knowledge of biopharmaceutical regulations and guidelines (FDA, ICH, EU Annex 1, and others as required) and keeps abreast of biopharmaceutical cGMP manufacturing regulatory environment changes.
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