Title

·         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

Professional Memberships              

·         Regulatory Affairs Professionals Society

·         Drug Information Association

Positions                    

- 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.