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SUMMARY OF QUALIFICATIONS
A regulatory affairs professional with over 25 years broad experience which combines science, business, and regulatory affairs. Successfully negotiated compliance matters with FDA, EPA, and other government agencies. Specific knowledge includes prescription and OTC drugs and drug components, animal cancer testing, pesticides, and cosmetics. Significant expertise in compliance management.

EDUCATION
Ph.D. Organic Chemistry, Purdue University, 1973
M.B.A. Management Science, University of South Carolina, 1974
M.S. Organic Chemistry, Purdue University, 1969
B.A. Chemistry, Rutgers University, 1967

SUMMARY OF ACHIEVEMENTS

  • Diverse consulting experience
  • Visited India to audit two nutrient manufacturing plants for an international marketing company. Issued comprehensive report which led to one site being chosen for toll manufacturing of a vitamin.
  • Drafted and upgraded Drug Master File (DMF) for a prescription drug active ingredient following an extensive CGMP audit of the facility. Provided assistance to technical, management, and operations personnel to assure adequate documentation for the manufacturing process of the ingredient and other products.
  • Drafted two Supplemental New Drug Applications (NDAs) for new manufacturing locations for a key finished dosage form of a prescription drug. Obtained prompt FDA approval and avoided threatened product shortage in the marketplace.
  • Provided comprehensive regulatory overview for an importer and distributor of chemical substances to assure compliance with diverse regulatory agencies including EPA, DOT, OSHA, and FDA.
  • Based on knowledge of a client's operations, drafted a response letter within 24 hours to an FDA Form 483 Inspectional Observations and successfully persuaded management to move it quickly to the agency. The 483 response adequately addressed FDA concerns and prevented further regulatory action by the agency.
  • Resolved client problems in diverse regulatory areas by assisting the creation of operational systems to handle data gathering and submissions. Such documentation included New Jersey DEPE Right-to-Know, air and water permit submissions, and distribution and review of MSDSs as required by OSHA. Such operational systems allowed clients to proceed with regulatory compliance without direct consultant involvement.

Extensive prior (corporate) regulatory affairs experience includes:

  • Created an NDA from scratch to provide the company with an option for compliance negotiations with the FDA.
  • Established regulatory systems to handle renewal of state licenses, federal reporting/registration, and periodic NDA reporting.
  • Prepared a response document which attained final FDA approval for an ANDA which had been pending for four years.
  • Personally researched and successfully defended a product's safety superiority advertising claims against a competitor's legal challenge.
  • Developed and implemented an environmental program that assured compliance with federal and state hazardous waste regulations and avoided significant environmental liability.

 

Acknowledged as an expert on government regulations and their impact. Presented seminars about regulatory topics to different industry groups:

  • Alerted the OTC drug industry through the Proprietary Association about the importance of and need to conform to RCRA regulatory requirements. This work was published in leading trade journals.
  • Presented regulatory training seminars through the Center for Professional Advancement on cosmetic product development and getting OTC drugs to market.
  • Presented for Technomics Publishing Company the first ever comprehensive seminar about how to use FDA guidelines.
  • Gave two presentations to trade associations in the pesticide industry about the safety of lawn care chemicals. One seminar included a debate against a physician representing an environmental group who expressed her views on the great hazards of pesticides.

As a Scientific Advisor to the American Council on Science and Health (ACSH) prepared thoroughly documented and scientifically solid reviews of contemporary health issues related to synthetic chemicals. Drafts were commented upon by world-renowned scientific experts and their sometimes conflicting editing suggestions had to be reconciled. Subjects evaluated included PCBs, pesticides, lawn care chemicals, pesticide residues, animal cancer testing, and natural carcinogens in food.

Developed a revolutionary approach to exemptions from the Consumer Product Safety Commission's child-resistant packaging requirements which demonstrated that deregulation will improve consumer safety. This approach potentially benefits industry through reduced packaging costs and consumer injury liability. The work was published in Drug & Cosmetic Industry magazine.

SUMMARY OF EXPERIENCE

REGULATORY AND SCIENTIFIC CONSULTANT 1985-date
Morganville, NJ
Assisted various companies with regulatory documentation and compliance management. Consultation involved communication and cooperation with research, marketing, medical, legal, clinical, statistical, information, quality control/assurance, regulatory, and management personnel.

DIRECTOR, REGULATORY AFFAIRS AND COMPLIANCE 1983-1985
Organon, Inc. West Orange, NJ
Maintained corporate compliance with FDA CGMPs. Coordinated, prepared, and submitted regulatory documents including NDAs, 510(k)s, ANDAs, and periodic reports. Approved all advertising and labeling for drugs and in vitro diagnostic products. Interacted directly with regulators concerning compliance and regulatory matters. Conducted all regulatory correspondence.

MANAGER, REGULATORY AFFAIRS 1977-1983
Block Drug Co., Inc. Jersey City, NJ
Prepared regulatory submissions to FDA, EPA, CPSC, and other agencies, including 510(k), IND, and OTC review documents. Prepared corporate comments on proposed regulations and served as liaison with trade groups on technical/regulatory matters. Monitored regulatory developments.

RESEARCH DIRECTOR 1974-1976
The Soap and Detergent Association New York, NY
Planned and administered the association research program. Prepared and reviewed technical submissions to federal and state regulatory agencies concerning human safety and environmental acceptability of product ingredients.

ACADEMIC POSITIONS
Purdue University, Department of Chemistry University of South Carolina, Computer Services

PERSONAL DATA
Publications: Bibliography on request
Married 32 years, two adult children
Volunteer (EMT) for local first aid squad since 1987. Photo

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