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D. in Pharmaceuticals or Chemistry preferred * 3-8 years of experience in ANDA litigation and a basic understanding of FDA regulatory law * Strong analytical skills with expertise in reviewing ...
You will be responsible for interfacing directly with the US FDA as the primary contact for the ... Act as the US Regulatory Leader for assigned project(s) and be responsible for the development ...
... DOT, FDA Good Manufacturing Practices, and other regulations. About the Role - The EHS Manager will lead compliance training and reporting to regulatory agencies, implement a new EHS management ...
Ensure all procured materials meet regulatory, quality, and safety standards (e.g., FDA, cGMP, NSF, USP). Inventory & Supply Chain Coordination: Work with production, R&D, and operations teams to ...
This role also serves as a resource to other faculty and staff on available protocols and general research topics, such as FDA, IRB, and GCP regulations. Responsibilities * Collaborate with the ...
... FDA guidelines and internal procedures. * Supervise the execution of batch records for API and intermediate production to ensure adherence to SOPs and regulations. * Supervise cleaning protocols ...
... additional regulatory approvals (CAP, FDA, ) relating to GHI Histopathology Assess the quality of slide preparations and troubleshoot procedures if necessary Prepare control slides and in ...