Regulatory Affairs VP-Glendale Heights
This position Directs Regulatory Affairs activities functioning as an independent and objective body that reviews and evaluates regulatory issues/concerns during the QbD product development process. Strong and proven QbD and CMC writing skills. The incumbent should have over eight years’ experience in preparing and writing the complete ANDA dossier and publishing it in validated eCTD format. Experience in filing the ANDA submissions via Electronic Submission Gateway (ESG). Thereafter manages the establishment registration, drug listing, amendments, supplements, and annual reports over the life cycle of the product.
The position ensures that the management and employees are in compliance with the rules and regulations of all regulatory agencies and that company policies and standard operating procedures are appropriate and are being followed.
• Serve as the primary corporate liaison / contact with domestic regulatory agencies (e.g., FDA Investigators,
Notified Body Auditors) regarding quality management systems.
• Complete CMC writing including QbD, Drug Substance and Drug product and Labeling sections.
• Discuss and guide the project team to respond to the CRLs in timely fashion.
• Review and critic product development reports.
• Host FDA and ISO audits.
• Maintain, prepare, review, and implement Regulatory Affairs standard operating procedures.
• ISO Management Representative.
• Review and monitor risk management process including post production risk.
• Manage the Customer Complaints Program:
• Medical Device Reports as appropriate to the FDA, Health Canada and the European Union.
• Post market surveillance monitoring, reports including product complaints and MDRs.
• Prepare and present to management tracking metrics for RA area activities, customer complaints/ MDRs.
• Manage the debarment list and MedWatch list review program.
• Manage product recalls and field removals.
• Manage State Licenses / Registration, and product listing to FDA.
• Manage, control, review, and monitor product labeling and advertising materials for compliance with FDA
• Prepare, review, implement and maintain quality manual, product technical files.
• Review and approve implementation of the design history file and device master record.
• Demonstrated experience of the aforementioned items along with accomplishment of 4 to 5 ANDA submissions to the US FDA and approval from the US FDA.
• Experience in multinational submissions will certainly be a plus.