Description:
The Manager, Regulatory Compliance, assembles a team for site wise and/or cross departmental discussions, oversees investigation, and completes Field Alert forms pertaining to issues and events that warrant notification to The Food and Drug Administration. The Manager, Regulatory Compliance is responsible for leading activities for the processing and management of product recalls, oversight and staffing of temporary workforce, response tracking and effectiveness check monitoring, follow up, closure and reporting writing respective to a product recall or market withdrawal.The Manager, Regulatory Compliance supports with establishing new, revising and maintaining Global Quality Standards current. The Manager, Regulatory Compliance has direct interface with Site Quality Heads and Functional Heads with respect to FAR and Recalls.
Essential Functions:
Additional Responsibilities:
Fosters a positive working environment and relationships with cross-functional partners and temporary workforce. Supports Global Quality Standards and Corporate SOPs to be kept current as they relate to Field Alerts, recalls etc. Support the continued growth of Amneal and the department to reach company and department goals and maintain complaint with regulatory agency requirments. Fosters and promotes a culture of teamwork, collaboration, accountability and drives for continuous improvements. Direct interface with Site Quality Heads with investigations associated with Field Alerts Writes trend analysis and risk assessments as needed