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:
Will be the contact person for the FDA and other regulatory agencies in regard to Field Alerts responses and will work closely with the FDA on resolutions as well as establishing new GQS and revises and maintains Global Quality Standards current. Manages and leads Global Notification Meetings with Senior Management and supports the dissemination of RAPID Alert escalations for Field Alert submissions.
Prepares and maintains FAR status report to CEO and Exec Management as well assists in completing Field Alert (FD 3331a) forms, as needed, and maintains and distributes reports on Field Alerts, Recalls and Drug Notifications as well as completes and issues to Illegitimate Drug Notification 3911 forms to FDA as needed
Leads and manages the recall workforce for processing of recalls. Staff requisitions, assignment of work, monitoring of work performance and hours and approval of timecards to support new and existing recalls.
Leads and manages the preparation for recalls including creating recall packages, completing Attachment b forms, and generates and submits in the status reports to FDA.
Manages the internal processing of Field Alerts and supports investigations, scheduling follow up meetings with sites and management team, maintains metrics and progress spreadsheets,
Compiles, analyzes, reports and provides repots on field alerts and recalls to Management as required. Creates and maintains metrics.
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
Education:
Bachelors Degree (BA/BS) Preferably in a science related field - Required
Experience:
5 years or more in Must demonstrate progressive responsibility in maintaining and enforcing GMPs, Regulatory Compliance with leadership experience.
3 years or more in At least 3 years required management of people, projects, functional area or a combination.
2 years or more in Thorough knowledge of FDA cGMPs (21 CFR Parts 210 & 211) and Part 820 requirements, understanding of ISO, EU and ICH requirements.
2 years or more in Managing Field Alert and Recall processing systems in Pharmaceutical, medical device or related industry
Skills:
Comprehensive knowledge/experience with Microsoft applications, spreadsheet/database maintenance and use. - Intermediate
Works independently and has experience with leading a team and fostering a team work environment - Advanced
Experience with data analysis for identifying trends and metric generation and reporting - Intermediate
Strong verbal and written communication skills - Advanced
Comprehensive technical writing skills and able to effectively apply critical thinking to assess and evaluate complex and critical Field Alert potential events and issues. - Intermediate
Specialized Knowledge:
Direct hands on experience in either manufacturing or development of a drug product or medical device a plus
Strong Knowledge base of use of computerized software and use of electronic systems, such as Caliber
Amneal is an Equal Opportunity Employer that does not discriminate on the basis of sex, age, race, color, creed, religion, national origin, sexual orientation, gender identity, genetic information, disability, veteran status, liability for service in the U.S. Armed Forces or any other characteristic protected by applicable federal, state, or local laws.
