Global Regulatory CMC Manager
Katalyst Healthcares & Life SciencesDetroit, MI, USjob_description.job_card.30_days_ago
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CMC Regulatory Strategy Development
Participate in the development of the CMC regulatory strategy for small molecules. These submissions include health authority briefing packages, IND / CTA, NDA, and MAA regulatory filings. Prepare and review CMC submission documents, registration dossiers, health authority briefing packages and responses to health authorities through collaborations with relevant line functions.
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Manager Regulatory Cmc • Detroit, MI, US
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