I function as your liason to manage, develop, implement and coordinate regulatory affairs and quality assurance with a focus on understanding, implementing and ensuring compliance for successful commercialization of products in target markets worldwide.
I help companies in four primary areas:
Strategically develop an effective CMC regulatory program
Evaluate and oversee capability of outside contract manufacturing organizations
Build and improve a phase appropriate GMP Quality System
Start-up new GMP manufacturing space
Direct development and implementation of quality systems to ensure product reliability, efficacy, and compliance
Drive regulatory strategy, communications, submissions, and manage inspections to enable successful commercialization of products and manufacturing licensing
Provide GxP Quality Assurance oversight of vendors and maintain quality agreements
Address and resolve nonconformances, deviations, and product complaints
Ensure organizational work processes conform with standard operating procedures
Oversee implementation of eQMS and other related systems
Oversee and execute compliance auditing program to fulfill regulatory requirements
Articulate complex Regulatory CMC issues and act as a liaison between Technical Operations and Regulatory Affairs.
Lead the development and implementation of all CMC regulatory strategy to support global development programs and market applications
Provide regulatory assessments of manufacturing changes within the change control system and filing strategy guidance for Technical Operations and Quality departments, including supporting preparation for facility inspections of vendor sites by health authorities when necessary
Assist with managing regulatory agency interactions and documents
Drives organizational development and continuous improvement through ongoing assessment of business needs and new opportunities. Effectively creates an engaging culture centered around operational excellence and innovation.
