Executive-SSSM

Key Responsibilities

• Support supervisor for End-to-end coordination for all projects, interacting with the API vendors and internal teams (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, placing orders, arranging technical documents to Analytical and Regulatory team s satisfaction, resolving ARD/QC s 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.
• Routine tracking of all shipment against orders and updating to internal team
• 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.