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CMC Regulatory Affairs Consultant

CMC Regulatory Affairs Consultant

Katalyst Healthcares & Life SciencesDallas, TX, US
30+ days ago
Job type
  • Full-time
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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Consultant • Dallas, TX, US

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