Track and evaluate governmental (FDA, DEA, etc) and State Board of Pharmacy regulations and their impact relative to the current and future business.
Oversee the company’s global quality strategies and policy development.
Directs the functional resources related to these areas and provides on-going, hands-on expertise.
Develops and implements comprehensive quality strategies for the company’s existing and newly created businesses.
Assures all pharmacy expansion designs meet the requirements and expectations of the FDA and State Board of Pharmacy guidelines and regulations.
Reviews proposed changes to regulated processes and / or products to identify regulatory implications.
Provides direction for significant deviation events that may impact compliance status.
Ensures compliance with all state and federal laws and regulations, including licensure and certification requirements.
Reviews Final Reports, Traditional Compounding Pharmacy and Outsource Facility Process Documentation, Clinical Protocols, and related documentation for compliance with cGMPs, USP 795 and/or 797, and other appropriate regulations and guidelines.
Manages and provides internal training for FDA and State Board of Pharmacy guidelines and regulations.
Acts as primary liaison for inspections and coordinates meetings with FDA, CDER, NABP, State Boards of Pharmacy, National Home Infusion Association and other regulatory agencies and related advocacy associations, including attorneys and consultants retained for the purposes of performing mock audits as needed
Represents the company with all domestic and international health authorities.
Interacts with key scientific, clinical research, and commercial personnel within and outside the company to ensure timely and accurate regulatory compliance.