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| Assoc.Dir NJ Open (J#28579) Title: Assoc.Dir Company: Mannkind Corporation Description Provide regulatory guidance and anticipated US and international CMC regulatory requirements to CMC and project teams. Contribute to the creation of World Wide Regulatory Affairs Regulatory Strategy for development projects by providing input on CMC issues and strategies. Establish CMC core document plan which incorporates all documentation required for INDs, NDAs, CTAs and MAAs. Review/supervise review of CMC documentation prepared for Regulatory submissions with respect to CMC regulatory adequacy, logic, context and consistency and provide feedback to technical disciplines. Assist in the assembly of the CMC dossier. Manage the preparation of responses to CMC comments/letters from worldwide health authorities. Provide regulatory input and guidance on interpretation of deficiency comments and guide the formulation of responses. Effect timely and appropriate regulatory management of CMC changes to products. Supervise preparation of regulatory documentation to update regulatory applications. More... | |||
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