Regulatory Compliance Expert in Global Fragrance and Chemical Registrations

Expertise

• Fragrance regulatory compliance U.S., Canada and Europe.
• TSCA (Hazard Assessments and Classifications) and GHS (Globally Harmonized System) identify requirements, chemical control requirements and labeling.
• U.S. PMN (Premanufacture Notices) and Canadian CEPA registrations.
• California PR 65, The Safe Drinking Water and Toxic Enforcement Act.
• Trained and proficient: EPA (Environmental Protection Agency), GLP (Good Laboratory Practice Standards) and GMP, (Good Manufacturing Practice) in compliance and reporting.
• Environmental chemistry and ecotoxicology.
• CMC (Chemistry, Manufacturing and Controls) equivalent regulatory affairs.
• CRO (Contract Research Organization) management experience.
• Regulatory compliance management, OSHA and other requirements.
• Manage and conduct and preparation of regulatory submissions including analytical, synthesis, bioanalytical, AME, environmental chemistry, and toxicology programs including overviews, rebuttals, and summaries.
• International marketing and managerial experience, providing overall budgeting, program management, planning, protocol development, implementation, and reporting.

Experience

Independent Consultant, 2012 - Present

Undisclosed Company, Director of Regulatory Affairs, 2000 - 2012

• Responsible for the preparation by the Regulatory Department of safety documentation for fragrance and flavor ingredients as requested by clients.
• These included but not limited to safety evaluations and labeling requirements of the EPA, FDA, Canada Health and Environmental Agencies, and European Authorities.
• Contracted and evaluated ecotoxicology and mammalian toxicity studies on Firmenich raw materials for TSCA and other global registrations.
• Prepared and filed PMNs and CEPA registrations for new chemicals and essential oils.
• Responsible for the preparation of MSDS and SDS under TSCA and GHS for Firmenich products sold in the U.S. and Canada.
• Vice Chair of the IFRA Environmental Task Force, Member of the UFRA/IOFI GHS Taskforce, and Member of the IFRA Scientific Affairs Committee.

American Cyanamid, Princeton, NJ, 1990 - 2000

Associate Director, Environmental Chemistry and Ecotoxicology

• Built and managed Chemistry and Toxicology Sections of MS/Ph.D. scientists and technicians with departmental budget of $10 million.
• Conducted, prepared submissions for and defended all environmental chemistry and ecotoxicology submission requirements in support of the chemical notification, global registration and re-registration of Cyanamid's agricultural products and Fort Dodge Industries' animal health products.
• Achieved 100% agency acceptance rate for regulatory submissions globally.
• Responsibilities included supervision of in-house staff, contract negotiation and administration of 30 U.S. and European CRO laboratories conducting and reporting 300 studies per year to meet tight deadlines of regulatory required submissions for new and existing compounds.
• Spearheaded division's first multi-functional teams to manage development of new compounds for chemistry and toxicology department.
• Planned, implemented, and managed Good Laboratory Practice procedures and safety programs for 100-member department with direct supervision of GLP coordinator and staff including writing and revision of all departmental SOPs. Co-wrote Ag Division Research and Development Safety Manual.
• Supervised the design and construction of new off-site chemistry lab. Directed its operations for six years.
• Initiated and developed efficient and effective procedures for collecting and recording of all study raw data generated within the department, including standardizing reporting and cataloguing format to ensure comprehensive information availability and accessibility.
• Directed the synthesis (preparation/purification) and characterization of all isotopically labeled test substances used within the Department by both in-house staff and contract laboratories.

Battelle Memorial Institute, Geneva , Switzerland and Ohio, U.S, 1988 - 1990

Department Manager, Biological Chemistry

• Managed 50 research professionals.
• Conducting research in metabolism, environmental chemistry, bioanalytical, and dose preparation and analysis for mammalian toxicology, for international life sciences companies.

Program Manager (Geneva, Switzerland)

• Marketed and Directed international chemical research program between U.S. and European divisions.
• Established GLP procedures and Chemical Notification Department.
• Designed and implemented marketing strategies to expand Battelle's market presence to the pharmaceutical and agrochemicals industries.

E. I Du Pont & Company, Wilmington, DE Research Supervisor, 1972 - 1988

• Managed team of 40 in the development and validation of methodology used to analyze crop protection products in plant and animal tissues, as well as soil and water at the ppb and ppt level.
• Organized and coordinated report activities for Magnitude of Residue and Environmental Fate studies.
• Interacted directly with Regulatory Agencies in Washington and Europe in defense of regulatory submissions.

Senior Research Chemist

• Developed cross-contamination methods to ensure product safety.
• Designed analytical procedures to ensure compliance with agricultural products manufacturing specifications and supported the manufacturing division directly and indirectly.

Research Chemist

• Synthesis chemist in Agricultural Products Department.

Education

• Ph.D. Organic Chemistry, University of Western Ontario, London, ON, Canada
• B.Sc. Chemistry, (With Honors), University of Western Ontario, London, ON, Canada