Katalyst HealthCares & Life Sciences
CMC Regulatory Affairs Consultant
Katalyst HealthCares & Life Sciences, Dallas, Texas, United States, 75215
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...
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...