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5.0 - 9.0 years
0 Lacs
ahmedabad, gujarat
On-site
As a Technical Support Specialist at Amneal Pharmaceuticals, you will be responsible for providing end-to-end coordination for all R&D projects in a variety of areas including product initiation, API sample evaluation, product development, ANDA submission, FDA queries, ANDA approval, and launch. Your role will involve collaborating with API suppliers and internal technical teams such as Analytical, Formulation, Regulatory, and QA/QC to address technical concerns, document issues, material quality, and meet requirements for ANDA submission and regulatory agency approvals. You will utilize your technical knowledge to conduct detailed reviews of API drug master files according to current US FDA...
Posted 3 months ago
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