Hiring For SSSM (Strategic Sourcing & Supply Management)

Job Description

Job Description : ( Technical Support) Support supervisor for End-to-end coordination for all R&D projects for the following flow. Product initiation API Sample evaluation --> Product Devt--> ANDA Submission --> FDA Query ANDA Approval --> Launch Activities include interaction with API suppliers and internal Technical teams i.e. Analytical, Formulation, Regulatory, QA/QC to resolve all technical concerns (Documents/analytical issues/material quality) and fulfil requirements for ANDA submission and Regulatory Agency deficiencies, along with Global launch for US and non-regulated markets. Use technical knowledge to perform in-depth review of API drug master file as per current US FDA expectations; identify deficiencies and formulate strategies to resolve them. Close coordination with Packaging material and Excipient vendors to arrange technical documents to Analytical and Regulatory teams satisfaction, resolving ARD/QCs technical issues by discussion with Raw material vendors Understanding the impact of changes in Raw material process/specifications and preparation of Change controls and coordinating with internal teams for timely closure Work across multiple time-zones to be in regular contact with global suppliers and cross functional teams within the organization for seamless project management. Actively organize and lead teleconferences with key stakeholders to monitor the progress, identify and resolve key issues for successful execution of projects. Data management for all relevant projects handled within the team Keep up-to-date with the changing market dynamics and FDA regulatory guidelines in the US Generic Industry. Interested candidate can share CV @ bhuvneshwari.rathore@amneal.com Subject Line : CV for SSSM