Strategic Regulatory Consultant
· 27+ years experience in pharmaceutical development and scientific regulatory affairs
· Independent consultant for 2 years, consultant for firms for 25 years
· Senior management roles, Director to Vice president of pharmaceutical development
· Clinical and Non-Clinical regulatory and CMC experience
Specific Areas of Expertise
· Strategic product development plan and preparation and execution, tactical planning and logistics, and program management
· Regulatory strategy development and implementation Bioanalytical method development
· Regulatory submission oversight, management, preparation, maintenance, and quality assurance
· Regulatory authority interactions, including serving as US Agent
· Regulatory compliance gap analysis and issue resolution
· Scientific, regulatory, and due diligence reviews of regulatory documents and submissions
· Regulatory and scientific document development, preparation, and quality assurance
· Technical/medical writing project management and quality assurance, including clinical study reports, submission documents, and submission components
· Regulatory Affairs Professionals Society
· Drug Information Association
- Independent Strategic Regulatory Consultant PharmaFacts, Inc.
- Principal Consultant Aptuit Consulting, Inc.
- Project Director, Global Regulatory Affairs PRA International
- Assistant Director, Regulatory Affairs Regulatory Consultants, Inc.
- Vice President, Pharmaceutical Development Beckloff Associates, Inc.