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.
Qualifications
Experience Required- 4yrs
Qualification -B.Pharm/ M.Pharm
About Us
Amneal is an equal opportunity employer. We do not discriminate based on caste, religion, gender, disability, or any other legally protected status. We believe in fostering a workplace that values diversity and inclusion.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Business Development and Sales
Industries
Pharmaceutical Manufacturing
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