Regulatory affairs, Quality Assurance (QA) and technical consulting for drugs, biologics, medical devices and functional pharmaceutical packaging

Technical Consultant #1555


Expertise

  • Regulatory affairs, Quality Assurance (QA) and technical consulting for drugs, biologics, medical devices and combination products for functional pharmaceutical packaging.
  • Regulatory affairs, quality assurance, compliance, and technical development consulting for; drugs, biologics, medical devices and combination products, in particular drug delivery devices and pharmaceutical packaging systems.

Experience

Independent Consultant, 2007 - Present

  • Expert advisement in medical devices and combination products, in particular drug delivery devices and pharmaceutical packaging systems, and respectively, specializing in regulatory affairs, quality assurance, compliance, technical development of drugs, and biologics.

Cardiome Pharma Corp., Vice President, Regulatory Affairs, 2005 - 2007

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

QLT Inc., Vice President, Regulatory Affairs, 2004 - 2005

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

Aventis Behring, Vice President World Wide Compliance, King of Prussia, PA, 2001 - 2003

  • Responsible for regulatory agency liaison for quality systems compliance, internal audit, compliance enhancement and best practices for plasma collection and plasma derived biologics manufacture.

Becton Dickinson & Company, Franklin Lakes, NJ, 1992 - 2001

Director Corporate Regulatory Affairs, 1995 - 2001

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

Director Regulatory Affairs and Quality Assurance, 1992 - 1995

  • 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.

Chiros International, Buckingham, PA, Principal Independent Consultant, 1990 - 1992

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

Schering-Plough Research Institute, Kenilworth, NJ, Director Regulatory Affairs, 1987 - 1990

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

Triton Biosciences, Shell Oil Company, Alameda, CA, Director Regulatory Affairs and Government Affairs, 1983 - 1987

  • 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, FDA, Bureau of Biologics, Bethesda, MD, 1970 - 1980

  • Chemist, Division of Blood and Blood Products, Plasma Derivatives Branch.
  • Research Chemist: Reviewer and FDA Inspector for the regulation of plasma protein therapeutics.
  • Research Chemist: Division of Bacterial Products, Allergenic Products Branch: Researched and reviewed allergenic extracts and atopic allergens.

National Institutes of Health, Bethesda, MD, 1970 - 1977

Health Scientist Administrator, 1975 - 1977

  • National Heart, Lung and Blood Institute, Division of Blood Diseases and Resources: Extramural programs manager for basic and clinical research on blood diseases, hemostasis, clotting factors, plasma fractionation, blood products, blood substitutes and biomaterials.

Grants Associate, 1974 - 1975

  • Division of Research Grants: 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, 1970 - 1974

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

Honors & Publications

Credentials

  • United States Pharmacopeia Pharmaceutical Waters Expert Committee
  • United States Pharmacopeia, Advisory Committee, Water & Parenterals
  • RAPS-RCAB, Regulatory Affairs Certified (RAC)
  • FDA Inspector
  • PHS Grants Associates Program, Governing Board
  • American Institute of Chemists Award, Philadelphia College of Pharmacy and Science

Academic and Professional Affiliations

  • Regulatory Affairs Professionals Society, Southern BC Chapter
  • Parenteral Drug Association, Combination Products Interest Group
  • Pennsylvania Biotechnology Association, Board of Directors
  • Pharmaceutical Manufacturers Association, Committee on Racemic Mixtures
  • Industrial Biotechnology Association, FDA Affairs Committee, Founder and Member
  • Advisory Committee on Biotechnology-California State Assembly

Education

  • Ph.D. Organic Chemistry, Temple University, Philadelphia, PA
  • B.Sc. Philadelphia College of Pharmacy and Science, Philadelphia, PA
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