Senior Consultant, Biologics Consulting Group, Inc., Philadelphia, PA.

Principal Consultant, Chimera Consulting, Philadelphia, PA.

• Independent consultant specializing in quality, regulatory affairs and development strategy for drugs, biologics, devices and combination products

Vice-President, Regulatory Affairs, Cardiome Pharma Corporation, Vancouver, BC.

• Department head responsible for regulatory submissions, strategy and regulatory agency liaison with therapeutic focus on anti-arrhythmic and other cardiovascular drugs

Vice-President, Regulatory Affairs, QLT Incorporated, Vancouver, BC.

• Department head responsible for regulatory submissions, strategy and regulatory agency liaison with therapeutic focus on ophthalmologic, dermatologic, urologic and oncologic drugs 

Vice-President World-Wide Compliance, Aventis Behring, King of Prussia, PA.

• Corporate Compliance department head responsible for regulatory agency liaison for quality systems compliance, internal audit, compliance enhancement and best practices for plasma collection and plasma derived biologics manufacture.

Director Corporate Regulatory Affairs, Becton Dickinson & Company, Franklin Lakes, NJ.

• Pharmaceutical Systems Division regulatory affairs department head. responsible for, submissions strategy and regulatory agency liaison for business divisions developing and marketing pharmaceuticals, drug delivery systems and functional pharmaceutical packaging

Director Regulatory Affairs and Quality Assurance, Becton Dickinson & Company, Franklin Lakes, NJ

• Transdermal Systems Division regulatory affairs department head responsible for submissions, strategy and regulatory agency liaison and quality systems management for development and registration of drug-device combination products employing novel electrically assisted transdermal drug delivery (iontophoresis) technology

Principal, Chiros International, Buckingham, PA.

• Independent consultant specializing in regulatory requirements, submissions and drug development strategies for development and registration of chiral drugs for pharmaceutical clients ranging from large companies to small biotechnology companies

Director Regulatory Affairs, Schering-Plough Research Institute, Kenilworth, NJ.

• Department head responsible for all submissions and regulatory liaison with FDA Divisions of cardio-renal, neuropharmacologic and generic drugs

Director Regulatory Affairs/Government Affairs, Triton Biosciences, Shell Oil Company, Alameda, CA.

• Department head responsible for regulatory submissions, strategy and FDA liaison for recombinant beta-interferon and project manager for development of fludarabine in collaboration with the National Cancer Institute

U.S. Public Health Service, Bethesda, MD.

Chemist, Food and Drug Administration, Bureau of Biologics, Division of Blood and Blood Products, Plasma Derivatives Branch (1970-1980)

• Reviewer and FDA Inspector for the regulation of plasma protein therapeutics.

Research Chemist, Division of Bacterial Products, Allergenic Products Branch, (1974).

• Research chemist and reviewer for allergenic extracts and atopic allergens,

Research Chemist, National Institutes of Health, (1977 – 1980)

Health-Scientist Administrator, National Heart, Lung and Blood Institute, Division of Blood Diseases and Resources (1975 – 1977)

• Extramural programs manager for basic and clinical research on blood diseases, hemostasis, clotting factors, plasma fractionation, blood products, blood substitutes and biomaterials.

Grants Associate, Division of Research Grants (1974 - 1975)

• One-year rotational internship in health-science administration, providing broad exposure to the structure, functions and programs of the NIH and sister agencies of the Public Health Service.

 Senior Staff Postdoctoral Fellow, National Institute of Dental Research (1970 – 1974)

• Intramural scientist, engaged in basic research on fibrin cross-linking, protein chemistry, peptide synthesis, enzyme mechanism, substrate specificity and kinetics.

OTHER RELATED EXPERIENCE

HONORS AND AWARDS

1966             American Institute of Chemists Award, Philadelphia College of Pharmacy and Science

PROFESSIONAL AND HONORARY SOCIETIES

ADDITIONAL TRAINING

• RAPS-RCAB, Regulatory Affairs Certified (RAC)