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.
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
- 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
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
- 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
- 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
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
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
DIRECTOR, REGULATORY AFFAIRS AND
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
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
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.
Purdue University, Department of Chemistry University of South Carolina, Computer Services
Publications: Bibliography on request
Married 32 years, two adult children
Volunteer (EMT) for local first aid squad since 1987. Photo
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