CMC Regulatory Affairs Consultant Job at Katalyst HealthCares & Life Sciences, Dallas, TX

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  • Katalyst HealthCares & Life Sciences
  • Dallas, TX

Job Description

Job Title

Responsibilities: Provide CMC regulatory strategies to support the clinical development and eventual marketing approval of investigational products. Lead the preparation and maintenance of the CMC / quality sections for regulatory submissions, including initial submission of IND, IMPD/CTA, NDA, MAA, and amendments to Health Authorities (HAs), and preparation of responses to queries from H...

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