Experience

Bergeson & Campbell, P.C.

• United States
• Law Practice
• 1 - 100 Employee

• Regulatory Consultant

  • Feb 2014 - Present



The Acta Group

• United States
• Chemical Manufacturing
• 1 - 100 Employee

• Regulatory Consultant

  • Feb 2014 - Present



3E Company

• Manager, US Authoring Services

  • Oct 2010 - Feb 2014

  Manager, US Authoring Services within 3E.



ISP

• Chemical Manufacturing
• 700 & Above Employee

• Manager, Hazard Communications

  • Jan 2008 - Oct 2010

  Assessed chemical substances and mixtures according to all global classification and labeling initiatives including Directive 67/548/EEC and CLP (EC 1272/2008), GHS, OSHA Hazard Communications Standard, Canadian WHMIS as well as aspects of Personal care (INCI) and Biocides labeling under FIFRA and PCPADeveloped training programs for R&D for hazard communications and labeling as well as for manufacturing sites for transportation of dangerous goods (ADR, TDG, 49CFR, IATA, IMDG).Integration of SDS/Labeling software into ERP systems for purpose of streamlining transportation processesResponsible for global creation, maintenance and management of all aspects of hazard communications including SDS and labels under applicable standards.



Ciba

• Chemical Manufacturing
• 500 - 600 Employee

• Manager, FDA Compliance and Expert Services Business

  • Oct 2003 - Dec 2007

  Assessed numerous global product lines for Food and Drug Administration (FDA) indirect food contact compliance Compiled and submitted Food Contact Notifications for various applications including adhesives, paper and paperboard additives and lubricants with incidental contact for not only internal global business, but also third party clientsManaged several aspects of Ciba Specialty Chemical's third party regulatory consulting business including EPA and FDA project issues; responsible for all product safety aspects in support of Water and Paper Treatment; Assigned health and safety classification and reviewed MSDS safety language for accuracyCoordinated and communicated toxicological and ecotoxicity testing and informationDeveloped MSDS language and provided assistance in implementation of new system for authoring documentsManaged a small group of regulatory specialists covering various aspects of product safety and regulatoryParticipated in several innovation management initiatives as a regulatory advisorPerformed ecological and toxicological risk assessments for internal and external customersProvided customer and technical support in areas of toxicology, ecology and product safety Responsible for TSCA coordination for business segment



Reichhold, Inc

• Corporate Toxicologist/EH&S

  • Feb 1997 - Oct 2003

  Assisted in globalization of emergency response program including training in internal computer based reporting system and process flowDesigned and administered global medical surveillance initiative as well as developed industrial hygiene program for large R&D facility (over 400 employees) including ergonomic assessments, noise, dust and chemical monitoring.Organized global effort in the standardization of a personal protective equipment program which included determining proper protection based on individual and task oriented risk as well as developing on-site training programsResearched toxicity of materials and related health warnings for all personnel globallyResponsible for tracking, communicating and assisting manufacturing sites to ensure global regulatory complianceThorough knowledge of EPA, OSHA, WHMIS and Canadian Provincial (British Columbia and Ontario) health and safety regulations as well as familiarity with European Union (EU) standards. Product Safety Toxicologist: main responsibility involved toxicological review of new research products for regulatory purposesAuthored material safety data sheets for 100+ product lines which included development of new MSDS text and translation as well as determination of international shipping and labeling requirementsExtensive work in chemical risk assessment for product safety and regulatory issues especially for pre-manufacturing notifications, new substance notifications and MSDS development Evaluated available software programs for applicability to assess quantitative risk when toxicological data was not readily available for new materialsInvestigated new materials for worldwide inventory status (TSCA, DSL, EINECS, etc.) Reviewed chemical composition of new and existing products for FDA approval and applicability for use in consumer goods (16 CFR); major project involved R&D of new products for various non-reinforced applications



Novartis (formerly Ciba-Geigy)

• Research Assistant

  • Oct 1995 - Dec 1996

  involved with the genetic manipulation of Arabidopsis thaliana and tobacco for pharmaceutical purposesExperience in handling radio labeled isotopes (P32)Tissue culture and sterile techniquesSkilled in a broad range of molecular genetic processes and the associated health/safety hazards